
Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Pharmaceutical Innovations; Inc. May-24-2012 Other-Sonic Generic Ultrasound Transmission Gel – Other-Sonic Generic Ultrasound Transmission Gel 250 mLHypoallergenicProduct Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body. Other-Sonic GENERIC ULTRASOUND TRANSMISSION GEL is being recalled due to possible microbial contamination. An FDA Safety Communication was issued for this product on April 18; 2012.
Pharmaceutical Innovations; Inc. May-24-2012 Other-Sonic Generic Ultrasound Transmission Gel – Other-Sonic Generic Ultrasound Transmission Gel 5 Liters HypoallergenicProduct Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body. Other-Sonic GENERIC ULTRASOUND TRANSMISSION GEL is being recalled due to possible microbial contamination. An FDA Safety Communication was issued for this product on April 18; 2012.
Baxa Corporation May-25-2012 Abacus TPN Calculating Software – Abacus TPN Calculating SoftwareProduct Usage:LIMS Windows-based program for order entry and TPN calculation. Ordering salt-based ingredients on an ion-based template resulted in medication errors when calculating amounts of ingredients required.
MOOG Medical Devices Group May-30-2012 Curlin Infusion Administration Set – Non-DEHP Admin Set with Non-Vented Spike and 0.2 Micron Filter Packaged Assembly; product code: 340-4130; Method of Sterilization using Ethylene Oxide.The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Moog Medical Device Group became aware on March 23; 2012 via customer complaint; of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
MOOG Medical Devices Group May-30-2012 Curlin Infusion Administration Set – Non-DEHP Microbore Admin Set with Non-Vented Spike and Needleless Injection Port Positive Pressure Package Assembly; product code: 340-4133; Method of Sterilization using Ethylene Oxide.The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Moog Medical Device Group became aware on March 23; 2012 via customer complaint; of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
MOOG Medical Devices Group May-30-2012 Curlin Infusion Administration Set – Non-DEHP Admin Set Non-Vented Spike and 1.2 Micron Filter ASV Packaged Assembly; product code: 340-4173; Method of Sterilization using Ethylene Oxide.The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Moog Medical Device Group became aware on March 23; 2012 via customer complaint; of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
MOOG Medical Devices Group May-30-2012 Curlin Infusion Administration Set – Non-DEHP Microbore Administration Set with Non-Vented Spike Packaged Assembly; product code: 340-4114; Method of Sterilization using Ethylene Oxide.The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Moog Medical Device Group became aware on March 23; 2012 via customer complaint; of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
MOOG Medical Devices Group May-30-2012 Curlin Infusion Administration Set – Non-DEHP Microbore Administrative Set with Female Luer Adapter Packaged Assembly; product code: 340-4115; Method of Sterilization using Ethylene Oxide.The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Moog Medical Device Group became aware on March 23; 2012 via customer complaint; of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
MOOG Medical Devices Group May-30-2012 Curlin Infusion Administration Set – Epidural Admin Set with Non-Vented Bag Spike and 0.2 Micron Filter Package Assembly; product code: 340-4126; Method of Sterilization using Ethylene Oxide.The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Moog Medical Device Group became aware on March 23; 2012 via customer complaint; of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
MOOG Medical Devices Group May-30-2012 Curlin Infusion Administration Set – Non-DEHP Admin Set with Non-Vented Spike and 1.2 Micron Filter Packaged Assembly; product code: 340-4128; Method of Sterilization using Ethylene Oxide.The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Moog Medical Device Group became aware on March 23; 2012 via customer complaint; of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
MOOG Medical Devices Group May-30-2012 Curlin Infusion Administration Set – Non-DEHP Admin Set with Non-Vented Spike and 1.2 Micron Filter Packaged Assembly; product code: 340-4128-V; Method of Sterilization using Ethylene Oxide.The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Moog Medical Device Group became aware on March 23; 2012 via customer complaint; of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
MOOG Medical Devices Group May-30-2012 Curlin Infusion Administration Set – Non-DEHP Microbore Administrative Set with Female Luer Adapter Packaged Assembly; product code: 340-4176; Method of Sterilization using Ethylene Oxide.The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Moog Medical Device Group became aware on March 23; 2011 via customer complaint; of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
MOOG Medical Devices Group May-30-2012 Curlin Infusion Administration Set – Non-DEHP Admin Set with Non-Vented Spike and 0.2 Micron Filter Packaged Assembly; product code: 340-4130-V; Method of Sterilization using Ethylene Oxide.The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Moog Medical Device Group became aware on March 23; 2012 via customer complaint; of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
MOOG Medical Devices Group May-30-2012 Curlin Infusion Administration Set – Non-DEHP Microbore Admin Set with Female Male Luer Locks and Y-Site with Check Valve Packaged Assembly; product code: 340-4137; Method of Sterilization using Ethylene Oxide.The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Moog Medical Device Group became aware on March 23; 2012 via customer complaint; of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
MOOG Medical Devices Group May-30-2012 Curlin Infusion Administration Set – Non-DEHP Epidural Yellow Striped Tubing Admin Set with Vented Vial Spike and 0.2 Micron Filter Packaged Assembly; product code: 340-4144; Method of Sterilization using Ethylene Oxide.The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Moog Medical Device Group became aware on March 23; 2012 via customer complaint; of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
MOOG Medical Devices Group May-30-2012 Curlin Infusion Administration Set – Non-DEHP Epidural Admin Set with 0.2 Micron Filter Non-Vented Bag Spike ASV Packaged; product code: 340-4165; Method of Sterilization using Ethylene Oxide. Moog Medical Device Group became aware on March 23; 2012 via customer complaint; of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
MOOG Medical Devices Group May-30-2012 Curlin Infusion Administration Set – Non-DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged; product code: 340-4166; Method of Sterilization using Ethylene Oxide.The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Moog Medical Device Group became aware on March 23; 2012 via customer complaint; of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
Class II recalls
Churchill Medical Systems; Inc. May-01-2012 Churchill Medical Systems 22Ga Winged Infusion Set – Churchill Medical Systems Winged Infusion Set; 22Ga; 1";Latex-Free Winged Infusion SetProduct Code: MBS-2210Huber type needle set used for the infusion of medical fluids into implantable ports. Mislabeled: MBS-2210 code on case label -22Ga Winged Infusion Set; ; however; the product label states 20Ga MBS-2010 code listed on device label.
Smith & Nephew; Inc. Endoscopy Division May-01-2012 Smith & Nephew 560P High Definition Camera Control Unit – Smith & Nephew 560P High Definition Camera Control UnitCatalog Number: 72201919The 560P camera system is configured to be connected as a stand-alone system on an endoscopic cart or tower. It is designed for use with the Smith & Nephew 560H 3-CCD High Definition Camera Head (560H camera head). The 560P camera system is designed to be used in conjunction with various peripheral devices; including the 560H camera head; Smith & Nephews 300 watt xenon light source; various flat panel displays; image capture devices; and print and video recording devices. May experience intermittent loss of video due to a defective board component
Wright Medical Technology Inc May-02-2012 VALOR(TM) TTC FUSION; INSTRUMENT KIT – VALOR(TM) TTC FUSION; INSTRUMENT KIT; REF 4150-KIT1; Wright Medical Technology; Inc.; 5677 Airline; Road; Arlington; TN 38002.The VALOR" Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity; arthritis; instability; and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcots Foot); Avascular Necrosis of the talus; failed joint replacement; failed ankle fusion; distal tibia fracture non-unions; Osteoarthritis; Rheumatoid Arthritis; and Pseudoarthrosis. The possibility exists that the handle of the targeting guide may rotate and/or break under normal usage.
Wright Medical Technology Inc May-02-2012 VALOR(R); TARGETING GUIDE – VALOR(R); TARGETING GUIDE; REF 4150011000; Wright Medical Technology; Inc.; 5677 Airline; Road; Arlington; TN 38002.The VALOR" Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity; arthritis; instability; and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcots Foot); Avascular Necrosis of the talus; failed joint replacement; failed ankle fusion; distal tibia fracture non-unions; Osteoarthritis; Rheumatoid Arthritis; and Pseudoarthrosis. The possibility exists that the handle of the targeting guide may rotate and/or break under normal usage.
St Jude Medical CRMD May-03-2012 QuickSite; QuickSite XL – Cardiac Resynchronization Therapy (CRT) Leads.Trade Name: QuickSite; QuickSite XLModel Numbers: QuickSite and QuickSite XL: Models 1056T; model 1058TIntended use: Left Ventricular Cardiac Resynchronization Therapy Lead Visual observations of externalized conductors due to abrasion of the silicone insulation in the distal portion of these QuickSite and QuickFlex leads.
St Jude Medical CRMD May-03-2012 QuickFlex; QuickFlex XL – Cardiac Resynchronization Therapy (CRT) LeadsTrade Name: QuickFlex; QuickFlex XLModel Numbers: QuickFlex and QuickFlex XL: model 1156T; model 1158TIntended use: Left Ventricular Cardiac Resynchronization Therapy Lead. Visual observations of externalized conductors due to abrasion of the silicone insulation in the distal portion of these QuickSite and QuickFlex leads.
Pentax Medical Company May-03-2012 EG-3870UTK; Pentax Ultrasound Video Gastroscope – EG-3870UTK; Pentax Ultrasound Video Gastroscope.The EG-3870UTK; Ultrasound Video Gastroscope; is intended to provide optical visualization via a video monitor of; ultrasonic visualization of; and therapeutic access to the Upper Gastrointestinal Tract; including; but restricted to the organs; tissues; and sub-systems; Esophagus; Stomach; Duodenum; Small Bowel; and underlying areas. The instrument is introduced per orally when indications consistent with the need for procedure are observed in adult and pediatric patient populations. Endoscope ultrasound balloon evacuation tube may become clogged with patient body fluid if users fail to properly follow instructions for pre-procedure check; operating the suction valve during procedure and pre-cleaning procedure.
Siemens Medical Solutions USA; Inc May-03-2012 ARTISTE; ONCOR and PRIMUS Linear Accelerator systems – Siemens-branded linear accelerator with a 550 TxT Treatment Table with a serial number <_ 1894. Siemens brand ARTISTE; ONCOR and PRIMUS Linear Accelerator systems include the 550 TxT" Treatment Table. Manufactured by: SIEMENS AG; MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath; GERMANY 95478. Product Usage: The intended use of the SIEMENS branded ARTISTE; ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. SIEMENS has received reports where a dropping down of the 550 TxT" Treatment Tablewas observed while the table was being moved downwards during operation by means of the hand control.
Bomimed Inc May-03-2012 BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades – BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades; MacIntosh and Miller styles – all sizes. Instrument is used to aid with intubation. On 9/1/2010 BOMImed; Inc. Winnipeg; MB; Canada initiated a recall of their BOMImed Integrated Reusable Laryngoscope Blades (Macintosh & Miller styles – all sizes); Model #OL-32D0 to OL-32D4 & OL-32E00; OL-32E0; OL-32E1; OL-32E2; OL-32E3; OL-32E4.
Hospira Inc. May-04-2012 LifeShield Primary Plumset – LifeShield Primary Plumset; CLAVE port; CLAVE Y-Site; 104 inch; 15 drops/mL; 48 sets per case; a sterile Rx device; Hospira Inc; Lake Forest; IL USA. Made in Costa Rica; product 120300412; list number 12030-12. Product Usage: For administration of I.V. fluids. The Lifeshield Primary Plumsets may cause a cassette test failure alarm when the set is loaded onto the infusion pump. A set which results in a cassette test failure alarm may result in delay in therapy; requiring medical intervention.
GE Healthcare; LLC May-04-2012 Optima MR450W with GEM. – GE Healthcare; Optima MR450W with GEM. Product Usage – The GEM Option for 1 .5T MRI systems is a set of receive-only RF surface coils designed for use with 1 .5T MRI systems manufactured by GE Healthcare. The GEM Option for 1 .5T MRI systems is indicated for use for: head; neck; brachial-plexus; spine; pelvis; hips; prostate; abdominal; cardiac; lower extremities; blood vessels; and long bone imaging. The nucleus detected is hydrogen. GE Healthcare is conducting a recall on Optima MR450W with GEM. During scanning of a patient; if an improperly torqued gradient connection exists; it may cause the gradient lead to produce excessive heat. If a second and compounding issue of improperly routed Rear Pedestal Air Supply Hose is also present; routed in such a way to cause the hose to come in contact with the overheated gradient lead
Siemens Medical Solutions USA; Inc May-07-2012 ARTISTE or ONCOR Linear Accelerators in combination with 160MLC – ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators that may be affected are: ARTISTE MV System; ONCOR Avant Garde ONCOR Impression ONCOR Impression Plus ONCOR Expression. Manufactured by Siemens AG; Medical Solutions; Kemnath; Germany; Registered by Siemens Medical Solutions; Concord; CA. ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.Product Model with Part Number:ARTISTE MV System; 8139789;ONCOR Avant Garde; 5863472;ONCOR Impression; 5857920;ONCOR Impression; Plus 5857912;ONCOR Expression; 7360204;ONCOR Expression; 7360717.ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. Siemens became aware of a potential safety risk related to the behavior of the 160 MLC when using the "Motion Stop" button followed by "Reset" several times during the treatment of one beam or one segment (issue 1). Additionally; there may be a potential for collision if the operator does not ensure clearance of the extended flat panel positioner for all gantry rotation angles (issue 2).
Sandhill Scientific; Inc May-07-2012 Insight – Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use by gastroenterologists; surgeons; and medically trained personnel for esophageal; biliary; and anorectal studies as an aid in documenting and diagnosing digestive motility disorders. Software error may produce incorrect esophageal contraction readings.
Siemens Medical Solutions USA; Inc May-08-2012 "Siemens – Siemens-branded ONCOR"" or PRIMUS"" linear accelerator with an OPTIVUE"" or MVision"" imaging system; Model Numbers: ONCOR Expression 7360717; ONCOR Impression Plus 5857912; ONCOR Avant Garde 5863472; PRIMUS HI 4504200;ARTISTE/ONCOR/PRIMUS systems are manufactured by: SIEMENS AG; MEDICAL SOLUTIONS;Roentgenstrasse 19-21; Kemnath; GERMANY 95478 Product Usage:Medical charged-particle radiation therapy system. The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer." The firm became aware of a potential issue with Siemens-branded ONCOR or PRIMUS linear accelerator with an OPTIVUE or MVision imaging system that has the potential collision problem of the imaging panel if the panel does not retract before the gantry rotates; this may result in patient injury.
Varian Medical Systems; Inc. Oncology Systems May-08-2012 True Beam – True Beam;Versions 1.0; 1.5.12.0 and below; 1.6.9.5 and below.Varian Medical Systems;Palo Alto; CA.Product Usage:TrueBeam Radiotherapy delivery system is intended to provide sterotactic radiosurgery and precision radiotherapy for lesions; tumors and conditions anywhere in the body where radiation treatment is indicated. A software anomaly has been identified in TrueBeam when using respiratory gating with patients in the prone position. The gating curve is inverted when a prone patient plan is loaded into TrueBeam.
Siemens Healthcare Diagnostics; Inc. May-08-2012 MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 47 – MicroScan Dried Overnight Gram Negative Panels;Panel type: Neg Breakpoint Combo Type 47; catalog number: B1017-417. Siemens Healthcare Diagnostics;West Sacramento; CA.For use in determining quantitative and / or qualitative antimicrobial agent susceptibility and / or identification to the species level of colonies; grown on solid media; of rapidly growing aerobic and facultative anaerobic gram-negative bacteria. Three lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels
Siemens Healthcare Diagnostics; Inc. May-08-2012 MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Urine Combo 55 – MicroScan Dried Overnight Gram Negative Panels;Panel type: Neg Urine Combo 55; Catalog Number B1017-409.Siemens Healthcare Diagnostics;West Sacramento; CA. Three lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels.
Siemens Healthcare Diagnostics; Inc. May-08-2012 MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 34 – MicroScan Dried Overnight Gram Negative Panels;Panel type: Neg Breakpoint Combo Type 34; catalog number: B1017-404. Siemens Healthcare Diagnostics;West Sacramento; CA. Three lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels.
Doctor’s Research Group; Inc. May-08-2012 Kryptonite Bone Cement – Doctors Research Group Kryptonite Bone Cement packaged in 5cc and 10 cc Kits:Product Codes:KRYP-US-Z-05 (5cc Kit)KRYP-US-Z -10 (10cc Kit)Product Usage:Kryptonite Bone Cement is a resinous material indicated for use in repairing cranial defects Bone cement strength and stiffness fall below specification at body temperature
O’Ryan Industries Inc May-09-2012 DISPOSA-SHIELD – DISPOSA-SHIELD. The Disposable Curing Shield For Your Curing Light. The disposable Disposa-Shield are sold in different sizes from 6 mm; 8 mm; 9 mm; 11 mm and 13 mm.The devices are Intended to be place over the tip of a dental curing light wand to protect the doctor’s and patient’s vision from exposure to high intensity light; soften contact of curing light against the teeth; and keep light guide cleaner; therefore maintaining good levels of light intensity for proper and fast curing The label of the O’Ryan Disposa-Shield listed the following: -Protect Doctor’s And Patient’s Vision From Exposure To High Intensity Light. -Soften Contact Of Light Guide Against Teeth. -Keep Light Guide Cleaner; Therefore; Maintaining Good Levels Of Light Intensity For Proper And Faster Curing.There are 25 devices per clear plastic bag when distributed in bulk and two devices per clear plastic zip lock type bag when distributed with curing lights.The "Sterilize Before Use" label is placed on a clear plastic bag containing 25 pieces of Disposa-Shield units distributed with all shipment of bulk Disposa-Shield.The "Sterilize Before Use" label is NOT placed on plastic zip lock type bag when distributed with two Disposa-Shield with curing lights.The product is labeled in parts:"***DISPOSA-SHIELD***The Disposable Curing Shield For Your Curing Light***STERILIZE BEFORE USE***O’RYAN INDUSTRIES***INSTRUCTIONS FOR INSTALLING DISPOSA-SHIELD***1. Remove and dispose of old DISPOSA-SHIELD***2. Sterilize wand tip***3. Simply stretch new DISPOSA-SHIELD over tip of wand***800-426-4311 or (360) 892-0447***(360) 892-6742 Fax***info@oryanindustries.com***’.The private label is labeled in parts: "***DISPOSA-SHIELD***The Disposable Curing Shield For Your Curing Light***ALMORE INTERNATIONAL ; INC***STERILIZE BEFORE USE***". Disposa-Shield Disposable Curing Shield is recalled due to lacking 510K; PM or IDE; and inadequate quality system.
MichClone Associates; Inc. May-09-2012 Sickle Heme – Sickle Heme; Hemoglobin S Solubility For Qualitative Determination of Hemoglobin S Test; ;100 Test Kit Product; No MCA 100; Contents: Two bottles of Sickle Cell Buffer; Two Bottles of Sickle Cell Powder; One Line Scale Two Dispensing Closures; For Invitor Diagnostics Use; Store at Room Temperature; Michclone Associates; Madison Heights; MI 48071.For the qualitative determination of positive or negative Sickle Cell Anemia present in Hemoglobin ; for in vitro diagnostic use only. Michclone Associate’s has received two complaints concerning the powder vial included in the 100 test kit observed producing pressure while sealed. When the powders are opened; the pressure from within the vial releases a small amount of powder into the air.This powder. if released near the face and inhaled can cause minor irritation resulting in sneezing and nasalcongestion. Investigation f
MichClone Associates; Inc. May-09-2012 Biotron – BioTron Sickle Cell Reagent Set; Screening test for the Presence of Hemoglobin S 2 x 100 ml Sickle Cell Buffer; 2 vials sickle Cell Reagent; Size 100 tests; Store 2-8 C; BioTron Diagnostics Inc; Hemet California; USA .For the qualitative determination of positive or negative Sickle Cell Anemia present in Hemoglobin ; for in vitro diagnostic use only. Two complaints received concerning the powder vial included in the 100 test kit observed producing pressure while sealed. When the powders are opened; the pressure from within the vial releases a small amount of powder into the air.This powder. if released near the face and inhaled can cause minor irritation resulting in sneezing and nasalcongestion. Investigation found no affect on the perf
MichClone Associates; Inc. May-09-2012 Sickle-Scan – Sickle- Scan Hemoglobin S Cell Reagent Set; Catalog No. 13-2101 100 Tests For the Determination of Hemoglobin S Two bottles Sickle Cell Solubility Buffer; 100 ml ; 2 vials Sickle Cell Solubility Powder; Size 100 tests; Store 20-30 C; Distributed by True-Medix Diagnostic Brooklyn; NY 11228; 800-952-3349. For the qualitative determination Hemoglobin S; for in vitro diagnostic use only. Two complaints concerning the powder vial included in the 100 test kit has been observed producing pressure while sealed. When the powders are opened; the pressure from within the vial releases a small amount of powder into the air.This powder. if released near the face and inhaled can cause minor irritation resulting in sneezing and nasalcongestion. Investigation found no affect on the perf
CaridianBCT; Inc. May-09-2012 COBE Spectra – Caridian BCT COBE Spectra System Blood Warmer; Catalog number 950000000. Potential for air entry into the fluid pathway of the COBE Spectra due to a leak at the return luer connection to an elevated bloodwarmer when directions for use are not followed.
International Medsurg Connection; Inc. May-10-2012 8" x 4" 16-ply Dual X-Ray Gauze – 8" x 4" 16-ply Dual X-Ray Gauze; hospital fold; banded in 10’s; 200 pieces per bag; 10 bags per case; Distributed By: International Medsurg Connection; Schaumburg; IL USA 1-847-619-9926; Made in China; item IMSGZXX8416-10For use to control bleeding and absorb fluid. The lots of X-Ray Gauze are contaminated with foreign material; including remnants of cotton seeds and lint.
International Medsurg Connection; Inc. May-10-2012 8" x 4" 16-ply X-Ray Gauze – 8" x 4" 16-ply X-Ray Gauze; hospital fold; banded in 10’s; 200 pieces per bag; 10 bags per case; Distributed By: International Medsurg Connection; Schaumburg; IL USA 1-847-619-9926; Made in China; item IMSGZX8416-10For use to control bleeding and absorb fluid. The lots of X-Ray Gauze are contaminated with foreign material; including remnants of cotton seeds and lint.
Siemens Medical Solutions USA; Inc May-10-2012 Siemens Axiom Sensis XP – Siemens Axiom Sensis XP diagnostic programmable computerDiagnostic programmable computer There is a potential malfunction in the connection of a Sensis EP system with Carto(R) 3 dedicated cable set (part number 14411343) with the Carto 3 system from Bionsense Webster.
Instrumentation Laboratory Co. May-10-2012 HemosIL von Willebrand Factor Activity Assay kit – Instrumentation Laboratory (IL)HemosiL von Willebrand Factor Activity Assay KitPart Number: 0020004700The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems Falsely elevated levels may be reported with the HemosIL von Willebrand Factor Activity assay.
Zimmer Inc. May-10-2012 Zimmer¿ 4.1 Trabecular Metal" Dental Implant – Zimmer Dental Trabecular Metal; TMT4B10 IMP TM 4.1MM MTX FULL;10MM; Rx; Sterile R; www.zimmerdental.com; Zimmer Dental; Carlsbad; CA 92008; USAThe Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth; especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region.(Catalog TMT indicates textured collar) This Zimmer Dental voluntary device recall resulted from an investigation into the February 2012 complaint involving an apical tip of a 4.1mm D Trabecular Metal Implant which separated from the implant assembly during surgery on a patient with a dense (Type D1); thick; inferior border. The recall correction includes adding precautions to the Instructions for Use regarding the placement of a 4.1mm
Zimmer Inc. May-10-2012 Zimmer¿ 4.1 Trabecular Metal" Dental Implant – Zimmer Dental Trabecular Metal Implant; TMM4B13; 4.1mm x13MM; 3.5 mm implant TM; MTX Rx; Sterile R; ; Zimmer Dental; Carlsbad; CA 92008; USAThe Trabecular Metal Dental Implant is designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth; especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region. This Zimmer Dental voluntary device recall resulted from an investigation into the February 2012 complaint involving an apical tip of a 4.1mm D Trabecular Metal Implant which separated from the implant assembly during surgery on a patient with a dense (Type D1); thick; inferior border. The recall correction includes adding precautions to the Instructions for Use regarding the placement of a 4.1mm
Zimmer Inc. May-10-2012 Zimmer¿ 4.1 Trabecular Metal" Dental Implant – Zimmer Dental Trabecular Metal; TMM4B10 TM 4.1MM MTX FULL;10 MM; Rx; Sterile R; www.zimmerdental.com; Zimmer Dental; Carlsbad; CA 92008; USAThe Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth; especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region. Catalog TMM indicates machined collar. This Zimmer Dental voluntary device recall resulted from an investigation into the February 2012 complaint involving an apical tip of a 4.1mm D Trabecular Metal Implant which separated from the implant assembly during surgery on a patient with a dense (Type D1); thick; inferior border. The recall correction includes adding precautions to the Instructions for Use regarding the placement of a 4.1mm
Zimmer Inc. May-10-2012 Zimmer¿ 4.1 Trabecular Metal" Dental Implant – Zimmer Dental Trabecular Metal; TMT4B13 TM 4.1MM MTX FULL;13 MM; Rx; Sterile R; www.zimmerdental.com; Zimmer Dental; Carlsbad; CA 92008; USAThe Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth; especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region. TMT catalog # indicates textured collar. This Zimmer Dental voluntary device recall resulted from an investigation into the February 2012 complaint involving an apical tip of a 4.1mm D Trabecular Metal Implant which separated from the implant assembly during surgery on a patient with a dense (Type D1); thick; inferior border. The recall correction includes adding precautions to the Instructions for Use regarding the placement of a 4.1mm
Zimmer Inc. May-10-2012 Zimmer¿ 4.1 Trabecular Metal" Dental Implant – Zimmer Dental Trabecular Metal; TMT4B11 IMP TM 4.1MM MTX FULL;11.5MM; Rx; Sterile R; www.zimmerdental.com; Zimmer Dental; Carlsbad; CA 92008; USAThe Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth; Page 4 of 6 especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region. This Zimmer Dental voluntary device recall resulted from an investigation into the February 2012 complaint involving an apical tip of a 4.1mm D Trabecular Metal Implant which separated from the implant assembly during surgery on a patient with a dense (Type D1); thick; inferior border. The recall correction includes adding precautions to the Instructions for Use regarding the placement of a 4.1mm
Zimmer Inc. May-10-2012 Zimmer¿ 4.1 Trabecular Metal" Dental Implant – Zimmer Dental Trabecular Metal Implant; TMM4B11; 4.1mm x11.5 MM; 3.5 mm implant TM; MTX Rx; Sterile R; Zimmer Dental; Carlsbad; CA 92008; USAThe Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth; especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region. Catalog TMM indicates machined collar. This Zimmer Dental voluntary device recall resulted from an investigation into the February 2012 complaint involving an apical tip of a 4.1mm D Trabecular Metal Implant which separated from the implant assembly during surgery on a patient with a dense (Type D1); thick; inferior border. The recall correction includes adding precautions to the Instructions for Use regarding the placement of a 4.1mm
Siemens Healthcare Diagnostics; Inc. May-10-2012 Stratus(R) CS Acute care(TM) NT – Stratus(R) CS Acute care(TM) NT – proBNP TestPak reagent (CPBNPM) The Stratus(R) CS Acute care(TM) NT – proBNP method (pBNP) is an in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT0proBNP) in heparinized plasma. In individuals suspected of having congestive heart failure (CHF); measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patient with acute coronary syndrome and heart failure. Firm has confirmed a low frequency of calibration failures due to slope errors that are not resolved with routine maintenance with the specific SCS Pro-BNP lots listed. This issue only causes the slope error failures but does not affect patient results when the calibration is within specifications.
Abbott Laboratories May-10-2012 ARCHITECT STAT Troponin-I Reagent Kit – ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro diagnostic test kit; each kit contains bottles of microparticles; conjugate and assay diluent; Abbott Laboratories; Abbott Park; IL 60064ARCHITECT STAT Troponin-I is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cardiac troponin-I in human serum and plasma on the ARCHITECT i System with STAT protocol capability. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI) and in the risk stratification of patients with acute coronary syndromes (including unstable angina and non-ST elevation) with respect to relative risk of mortality; myocardial infarction; or increased probability of ischemic events. The lot of Troponin-I is demonstrating a shift in expected results in some cases; and varies from kit to kit. A concentration change of up to +/-55% could occur when switching kits without recalibrating.
Cordis Corporation May-10-2012 Transhepatic Biliary Stent System – Product is labeled in part: Inner Label "***SMART Control Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. CONTROL Nitinol Stent Transhepatic Biliary System***Assembled in Mexico***Cordis Corporation 14201 North West 60th Avenue Miami Lakes; Florida 33014; USA***Cordis S.M.A.R.T. CONTROL BILIARY***Cordis a Johnson & Johnson company***Endovascular***" Catalog C10080MB Lot No. 15535360. Catalog C10080SB Lot No. 15530747. Catalog C12030SB Lot No. 15530756. Catalog C12040SB Lot No. 15530755. Catalog C12060SB Lot No’s. 15535363; 15569685. Catalog C12080MB Lot No. 15530757 Catalog C14040SB Lot No’s. 15530754; 15557313. Catalog C14060SB Lot No’s. 15530753; 15557311. Catalog C14080SB Lot No. 15535361. Indicated for palliation of malignant neoplasms in the biliary tree. Cordis Corporation is recalling 32 lots of Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System and S.M.A.R.T. Control Nitinol Stent Transhepatic Biliary System. There is a potential for a sterility breach due to holes or tears in the Tyvek packaging.
Cordis Corporation May-10-2012 Transhepatic Biliary Stent System – Product is labeled in part: Inner Label "***S.M.A.R.T. Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System***Assembled in Mexico***Cordis Corporation 14201 North West 60th Avenue Miami Lakes; Florida 33014; USA***Cordis S.M.A.R.T. TRANSHEPATIC BILIARY STENT***Cordis a Johnson & Johnson company***Endovascular***" Catalog C06120MB Lot No’s. 15530111; 15535366; 15556361; 15560541; 15562698. Catalog C06150MB Lot No’s. 15530115; 15536150; 15556366; 15560543. Catalog C07120 MB Lot No’s. 15530114; 15556368; 15560545; 15562701. Catalog C07150MB Lot No’s. 15530113; 15556371; 15560546. Catalog C08120MB Lot No’s. 15530112. Catalog C08150MB Lot No’s. 15535365; 15556374; 15562702. Indicated for palliation of malignant neoplasms in the biliary tree. Cordis Corporation is recalling 32 lots of Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System and S.M.A.R.T. Control Nitinol Stent Transhepatic Biliary System. There is a potential for a sterility breach due to holes or tears in the Tyvek packaging.
Siemens Healthcare Diagnostics; Inc. May-11-2012 Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge – Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridgeProduct Usage:The TPSA method is an in vitro diagnostic test for the quantitative measurement of total prostate specific antigen (PSA) in human serum and plasma on the Dimension Vista(R) System Siemens has confirmed a report of leaking Flex(R) reagent cartridge lot 11300BB from Dimension Vista(R) TPSA; when a leaking Flex(R) is used; patient test results may be falsely depressed.
Haemacure Corporation May-11-2012 HemaSyst; Dual cannula Tip with Adapter 16 ga. x 4" (10.2 cm) – HemaSyst; Dual Cannula Tip with Adapter 16 ga. x 4" (10.2 cm). Product is labeled in part:"***Pouch label***HAEMACURE***HemaSyst***tm***Contents: One ***DUAL CANNULA TIP***WITH ADAPTER***16 ga. x 4" (10.2 cm)***REF H-1604*** CE 0297***LOT 111144***2014/10***40680b/20004-02***CAUTION: U.S. Federal Law restricts this device to sale by or on the order of a licensed physician (or properly licensed practitioner).***Contents of unopened undamaged package are sterile***CE 0297***Manufactured by: ***Micromedics*** St. Paul; MN 55121-1385 USA***Distributed by:***Haemacure Corporation***Sarasota; FL 34236 USA***Toll Free 1-877-872-4583***www.haemacure.com***Box label***Contents: 5 packages of 1 each***DUAL CANNULA TIP***WITH ADAPTER***16 ga. x 4" (10.2 cm)***REF H-1604***CE 0297***STERILE EO***LOT 11144***2014/10***40681B/20544***".Sterile; single-use instrument for the application of two liquids. This product has been recalled due to the lot number being different on the box and pouch. The lot number on the box label was incorrectly printed as 11144 instead of 111144. The pouch label referenced the correct lot number; 111144.
GF Health Products; Inc./d.b.a.Basic American Metal Products May-11-2012 LUMEX A Graham-Field Brand; Bed End Sert – LUMEX A Graham-Field Brand; Bed End Sert. Low/Full-electric; Plastic Panels; Item 690-7604-000 Manufactured for : GF Heath Products; Inc.; Atlanta; Georgia 30360 Made in China.LUMEX A Graham-Field Brand; Bed End Sert. Low/Full-electric; Walnut Panels; Item 690-7004-000 Manufactured for : GF Heath Products; Inc.; Atlanta; Georgia 30360 Made in China.Therapeutic bed intended for home use. GF Health Products; Inc.; is conducting a recall on the Lumex Patriot Full Electric Homecare "Bed Ends" manufactured 3/27/09; 5/9/09; 5/30/09 and 6/20/09. The supplier deviated from the print specifications of a machined pin to a sheared pin. This deviation has the potential to provide room for the pin to move during use. If failure were to occur; the bed could descend rapidly causing non-typic
Steris Corporation May-11-2012 Evolution steam sterilizers – The Evolution steam sterilizers; manufactured by Steris Corporation; utilize a loading system to assist the operator in transporting; loading and unloading items to be sterilized. It consists of two major components: -Loading Car: Shelving unit which holds the items to be sterilized; and the -Transfer Carriage: Wheeled unit which loads/unloads the loading car and transports it from one location to another. Product shipped in crate.Product Usage:The Evolution Transfer Carriage is a wheeled unit which loads/unloads the sterilizer loading car and transports it from one location to another. Through Customer feedback and field service experience; STERIS learned that operators may experience difficulty when inserting or removing equipment from the Evolution sterilizer using the transfer carriage due to the following issues with the transfer carriage. 1) Deformation of the latch pin or cracked ball bearings preventing the roller from turning.2) The rollers on the ends of the pivot a
Terumo Cardiovascular Systems Corp May-11-2012 CAPIOX FX Hollow Fiber Oxygenator – Terumo Custom Cardiovascular Procedure Kit- CUSTOM X-COATED LOW PRIME 3/8 x1/2 packProduct Code:72015-05 Manufactured to the design and specifications of the purchaser/user) for the application it is intended. Loose connections (i.e.; connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
Terumo Cardiovascular Systems Corp May-11-2012 CAPIOX FX Hollow Fiber Oxygenator – Terumo Custom Cardiovascular Procedure Kit- CUSTOM X-COATED LOW PRIME 3/8 Product Code:72015-04Manufactured to the design and specifications of the purchaser/user) for the application it is intended. Loose connections (i.e.; connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
Terumo Cardiovascular Systems Corp May-11-2012 CAPIOX FX Hollow Fiber Oxygenator – Terumo Custom Cardiovascular Procedure Kit-: CUSTOM X-COATED LOW PRIME Product Code:72015-03 Manufactured to the design and specifications of the purchaser/user) for the application it is intended. Loose connections (i.e.; connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
Terumo Cardiovascular Systems Corp May-11-2012 CAPIOX FX Hollow Fiber Oxygenator – Terumo Custom Cardiovascular Procedure Kit-PEDIATRIC PACKProduct Code: 71062-01 Manufactured to the design and specifications of the purchaser/user) for the application it is intended. Loose connections (i.e.; connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
Terumo Cardiovascular Systems Corp May-11-2012 CAPIOX FX Hollow Fiber Oxygenator – Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended.X-COATED PEDIATRIC 1/4X3/8 RX15 PACKProduct Code: 72225-01 Loose connections (i.e.; connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
Terumo Cardiovascular Systems Corp May-11-2012 CAPIOX FX Hollow Fiber Oxygenator – Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended.Cardiovascular Custom Procedure Kit AdultProduct Code: 71060-01 Loose connections (i.e.; connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
Terumo Cardiovascular Systems Corp May-11-2012 CAPIOX FX Hollow Fiber Oxygenator – Terumo Custom Cardiovascular Procedure Kit- X-COATED PERFUSION PK FX15RW30Product Code:73679Manufactured to the design and specifications of the purchaser/user) for the application it is intended. Loose connections (i.e.; connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
Terumo Cardiovascular Systems Corp May-11-2012 CAPIOX FX Hollow Fiber Oxygenator – Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended.X-COATED FX15RE40 PACKProduct Code: 73484 Loose connections (i.e.; connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
Terumo Cardiovascular Systems Corp May-11-2012 CAPIOX FX Hollow Fiber Oxygenators – Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended FX15RE40 PACK Product Code:66031 Loose connections (i.e.; connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
Terumo Cardiovascular Systems Corp May-11-2012 CAPIOX FX Hollow Fiber Oxygenators – Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended.FX15RE40 PACK Product Code:66024 Loose connections (i.e.; connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
Terumo Cardiovascular Systems Corp May-11-2012 CAPIOX RX Hollow Fiber Oxygenators – Terumo Custom Cardiovascular Procedure Kit (manufactured to the design and specifications of the purchaser/user) for the application it is intended by the user. X-COATED CHANGE OUT PACK WITH FX15EProduct Code: 74257 Loose connections (i.e.; connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
Terumo Cardiovascular Systems Corp May-11-2012 CAPIOX FX Hollow Fiber Oxygenator – Terumo Custom Cardiovascular Procedure Kit- X-COATED PERFUSION PK FX15RE40Product Code:73673Manufactured to the design and specifications of the purchaser/user) for the application it is intended. Loose connections (i.e.; connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
Terumo Cardiovascular Systems Corp May-11-2012 CAPIOX FX Hollow Fiber Oxygenator – Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended.X-COATED FX15 ADULT PACK Product Code: 73399 Loose connections (i.e.; connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
Mitaka USA; Inc. May-11-2012 Point Setter – Mitaka Point Setter; holding system for surgical instruments.Holding surgical instruments during operating procedures. Use of a potentially weaker spring in the device than required to meet specifications to hold the Point Setter ARM in place during surgery.
CaridianBCT; Inc. May-11-2012 Trima Accel – Trima Accel Automated Blood Collection System; catalog number 917000000; Caridian BCT; Lakewood; CO 80215 USA.Product Usage:Automated Blood Collection System for use in humans. Labeling clarification and software updates to include fixes for end of run summaries; increasing boot reliability; corrections to the double red blood cell count collection TBV limit; and to be in compliance with the most current FDA guidance for post donation platelet count targets.
Materialise USA LLC May-14-2012 N-K Flex Pin Guides – PATIENT SPECIFIC INSTRUMENTSN-K FLEX PIN GUIDES (FEMUR AND TIBIA)NONSTERILE ~ MUST BE STERILIZED PRIOR TO USEPatient ID ..- 0864-R3 Manufactured by Materialise; Plymouth; MI Distributed by Zimmer; Warsaw IN.Patient specific instrument is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient image scans. March 23; 2012 a field representative reported patient specific –0242 L tibia guide case packaging contained a different patient specific ..-0864-R tibia guide. The two patient specific products had been switched in packaging. Neither products had been delivered to the end user.
Materialise USA LLC May-14-2012 LPS-Flex Pin Guides – PATIENT SPECIFIC INSTRUMENTSLPS-FLEX PIN GUIDES (FEMUR AND TIBIA)NONSTERILE ~ MUST BE STERILIZED PRIOR TO USEPatient ID–0242-LFManufactured by Materialise; Plymouth; MI Distributed by Zimmer; Warsaw IN.Patient specific instrument is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient image scans. March 23; 2012 a field representative reported patient specific -0242-L tibia guide case packaging contained a different patient specific -0864-R tibia guide. The two patient specific products had been switched in packaging. Neither products had been delivered to the end user.
Captiva Spine; Inc May-14-2012 Spinal Intervertebral body Fixation Orthosis – Instructions For Use: "***SmartLOX***Instructions for Use Cervical Plate System***STERILIZATION***The SmartLOX Cervical Plate System components are supplied clean and not sterile. All implants and instruments should be cleaned and sterilized prior to surgery. AORN recommended practices for in hospital sterilization should be followed. Sterilization testing of components has shown the following recommendations for sterilization are effective Method: Steam***Cycle: Pre vacuum***Temperature 270 F (132 C)***Exposure Time: 3 minutes***Contact Information: Captiva Spine Inc. 967 Alternate AA #1 Jupiter; FL 33477. Tel: 877-772-5571***CAPTIVA SPINE***".Intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Captiva Spine has initiated a correction of the SmartLOX Instructions for Use (IFU) for SmartLOX Cervical Plate System. The pre vacuum sterilization cycle [270 (132 C) for 3 minutes] has not been validated.
Thera Test Laboratories; Inc. May-14-2012 RF IgA Calibrator – RF IgA Calibrator; a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in vitro diagnostic; TheraTest Laboratories; Lombard; IL 60148; component catalog #12833; kit catalog #303-305. The TheraTest EL-RF/3 is intended as an aid to the diagnosis of Rheumatoid Arthritis (RA). The RF IgA Calibrator component of the EL-RF/3 Rheumatoid Factor test system may be unstable; resulting in a drop in the RF IgA calibrator OD value which could invalidate an RF IgA test run.
North Coast Medical Inc May-14-2012 Norco Shoulder Pulley – Norco Shoulder PulleyDistributed by North Coast Medical; Gilroy; CA.Used to improve range of shoulder movement and coordination following a stroke; shoulder injury or surgery. Potential for plastic D-ring to break during use and cause injury.
Zimmer Inc. May-14-2012 NexGen CompleteKnee Solution; Prolong – 00595202010; NexGen CompleteKnee Solution; Prolong; Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 10mm Height; Sterile; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CompleteKnee Solution; Prolong – 00595202012; NexGen CompleteKnee Solution; Prolong; Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 12mm Height; Sterile; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complet Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CompleteKnee Solution ; Prolong – 00595202014; NexGen CompleteKnee Solution; Prolong; Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 14mm Height; Sterile; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CompleteKnee Solution; Prolong – 00595202017; NexGen CompleteKnee Solution; Prolong; Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 17 mm Height; Sterile; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CompleteKnee Solution;Prolong – 00595202020; NexGen CompleteKnee Solution; Prolong; Highly Crosslinked Polyethylene Micro Articular Surface Size Purple/A E Micro 20 mm Height; Sterile; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CompleteKnee Solution; Prolong – 00-5970-02023; NexGen CompleteKnee Solution; Prolong; Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert; Size Purple/A E Micro 23mm Height; Sterile; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CompleteKnee Solution; Prolong – 90595202012; NexGen CompleteKnee Solution; Prolong; Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert; Size Purple/A E Micro 12 mm Height; Sterile; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CompleteKnee Solution Prolong – 00-5976-020-23 NexGen Complete Knee Solution; Prolong; Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert; Size Purple/A E Micro 23 mm Height; Sterile; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CompleteKnee Solution Prolong – 90595202017; NexGen Complete Knee Solution; Prolong; Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert; Size Purple/A E Micro 17 mm Height; Sterile; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen Complete Knee Solution; Prolong – 90-5952-020-20; NexGen Complete Knee Solution; Prolong; Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert; Size Purple/A E Micro 20mm Height; Sterile; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CR Complete Knee Solution – 00-5970-020-09; NexGen CR Complete Knee Solution; Articular Surface regular constraint; Size Purple; Height; 9 mm CR Sterile; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CR Complete Knee Solution – 00-5970-020-10; NexGen CR Complete Knee Solution; Articular Surface regular constraint; Size Purple; Height; 10 mm CR Sterile; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CR Complete Knee Solution – 00-5970-020-12; NexGen CR Complete Knee Solution; Articular Surface regular constraint; Size Purple; Height; 12 mm CR Sterile; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CR Complete Knee Solution – 00-5970-020-14; NexGen CR Complete Knee Solution; Articular Surface regular constraint; Size Purple; Height; 14 mm CR Sterile; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CR Complete Knee Solution – 00-5970-020-17; NexGen CR Complete Knee Solution; Articular Surface regular constraint; Size Purple; Height; 17 mm CR Sterile; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CR Complete Knee Solution – 00-5970-020-20 NexGen CR Complete Knee Solution; Cruciate Retaining (CR) Articular Surface Regular Constraint; Size Purple; AE Micro 20 mm Height ; Use With Plate 1;2 (5.5 MM under the Condyles) Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CR Complete Knee Solution – 90-5970-020-09; NexGen CR Complete Knee Solution; Cruciate Retaining (CR) Articular Surface Regular Constraint; Size Purple; AE Micro 9 mm Height ; Use With Plate 1;2 (5.5 MM under the Condyles) Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CR Complete Knee Solution – 90-5970-020-10; NexGen CR Complete Knee Solution; Cruciate Retaining (CR) 10 MM Height ; Use With Plate 1;2 Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGenNexGen CR Complete Knee Solution – 90-5970-020-12; NexGen CR Complete Knee Solution; Cruciate Retaining (CR) Articular Surface Regular Constraint; Size Purple; AE Micro 12mm Height ; Use With Plate 1;2 Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CR Complete Knee Solution – 90-5970-020-14; NexGen CR Complete Knee Solution; Cruciate Retaining (CR) Articular Surface Regular Constraint; Size Purple; AE Micro 14mm Height ; Use With Plate 1;2 Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CR Complete Knee Solution – 90-5970-020-17; NexGen CR Complete Knee Solution; Cruciate Retaining (CR) Articular Surface Regular Constraint; Size Purple; AE Micro 17mm Height ; Use With Plate 1;2 Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CR Complete Knee Solution – 90-5970-020-20; NexGen CR Complete Knee Solution; Cruciate Retaining (CR) Articular Surface Regular Constraint; Size Purple; AE Micro 20mm Height ; Use With Plate 1;2 Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CR Complete Knee Solution – 00-5972-020-09; NexGen CR Complete Knee Solution; Cruciate Retaining (CR) Articular Surface Regular Constraint; Size Purple; AE Micro 9mm Height ; ( 5.5MM under the Condyles) Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGenNexGen CR Complete Knee Solution – 00-5972-020-10; NexGen CR Complete Knee Solution; Cruciate Retaining (CR) Articular Surface Regular Constraint; Size Purple; AE Micro 10mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CR Complete Knee Solution – 00-5972-020-12; NexGen CR Complete Knee Solution; Cruciate Retaining (CR) Articular Surface Regular Constraint; Size Purple; AE Micro 12mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CR Complete Knee Solution – 00-5972-020-14; NexGen CR Complete Knee Solution; Cruciate Retaining (CR) Articular Surface Regular Constraint; Size Purple; AE Micro 14 mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CR Complete Knee Solution – 00-5972-020-17; NexGen CR Complete Knee Solution; Cruciate Retaining (CR) Articular Surface Regular Constraint; Size Purple; AE Micro 17mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CR Complete Knee Solution – 00-5972-020-20; NexGen CR Complete Knee Solution; Cruciate Retaining (CR) Articular Surface Regular Constraint; Size Purple; AE Micro 20mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CR Complete Knee Solution – 00-5976-020-10; NexGen CR Complete Knee Solution; Cruciate Retaining (CR) Articular Surface Anterior Constrained AC; Size Purple; AE Micro 10mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use; tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is expandable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CR Complete Knee Solution – 00-5976-020-12; NexGen CR Complete Knee Solution; Cruciate Retaining (CR) Articular Surface Anterior Constrained AC; Size Purple; AE Micro 12mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use; tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CR Complete Knee Solution – 00-5976-020-17; NexGen CR Complete Knee Solution; Cruciate Retaining (CR) Articular Surface Anterior Constrained AC; Size Purple; AE Micro 17mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use; tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen CR Complete Knee Solution – 00-5976-020-20; NexGen CR Complete Knee Solution; Cruciate Retaining (CR) Articular Surface Anterior Constrained AC; Size Purple; AE Micro 20mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use; tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is expandable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – 00-5952-031-10; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Yellow A-E Micro 10mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – 00-5952-31-12; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Yellow A-E Micro 12mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – REF 00-5952-031-14; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Yellow A-E Micro 14mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – REF 00-5952-031-17; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Yellow A-E Micro 17mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – REF 00-5952-031-20; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Yellow A-E Micro 20mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – REF 00-5972-031-09; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 9mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – REF 00-5972-031-10; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 10mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – REF 00-5972-031-12; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 12mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – REF 00-5972-031-14; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 14mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – REF 00-5972-031-17; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 17mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – REF 90-5952-031-17; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Yellow/A-E 17 mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – REF 90-5972-031-20; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 20 mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 NexGen Complete Knee System – REF 00-5970-031-09; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 9 mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – REF 00-5970-031-10; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 10mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – REF 00-5970-031-12; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 12mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – REF 00-5970-031-14; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 14mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – REF 00-5970-031-17; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 17 mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nextgen Complete Knee System – REF 00-5970-031-20; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 20 mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – REF 90-5970-031-09; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 9mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – REF 90-5970-031-10; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 10mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – REF 90-5970-031-12; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 12mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – REF 90-5970-031-14; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 14 mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – REF 90-5970-031-17; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 17 mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – 90-5970-031-20; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 20 mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – REF 00-5972-031-20; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 20mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – 00-5976-031-10; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow /A-E Micro 10mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – 00-5976-031-12; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface AC Size Striped Yellow 12 mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – 00-5976-031-14; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface AC Size Striped Yellow 14 mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – 00-5976-031-17; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface AC Size Striped Yellow 17 mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – 00-5976-031-20; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface AC Size Striped Yellow 20 mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – 00-5970-031-23; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Striped Yellow 23 mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – 00-5972-031-23; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 23 mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Zimmer Inc. May-14-2012 Nexgen Complete Knee System – 00-5976-031-23; Nextgen Complete Knee System; Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface AC Size Striped Yellow 23 mm Height ; Sterile R; Rx ;Zimmer; Inc. Warsaw; INThe NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9; 10; 12; 14; 17; or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ;integrated; with an extensive cruciate retaining; cruciate substituting; and fully constrained component configurations; design specific; conforming surfaces; femoral and tibial augmentation. The femoral; patellar; articular surface; and tibial base plate components should be design specific to the condition and availability of the bone stock; and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components. Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur; even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are
Fresenius Medical Care Holdings; Inc. May-15-2012 Naturalyte Acid Concentrate – Fresenius Medical Naturalyte Acid Concentrate for bicarbonate Dialysis 45x ; 55 gallons (208.2 Liters)Cat. No. 13-2251-0.NaturaLyte liquid acid concentrate is formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates. Sodium content does not meet product requirements
Galil Medical; Inc. May-16-2012 17G Cryoablation Needle Holder – Galil Medical; 17G Cryoablation Needle Holder FPRPR 4014; Rx only; Sterile EO.Product Usage:Galil Medicals 17G Cryoablation Needle Holder (Needle Holder) is intended for use only with a Galil Medical Needle Testing Device (NTD). The NTD; a component used when performing cryogenic destruction of tissue with a Galil Medical Cryoablation System; is intended for performing a Needle Integrity and Functionality Test in preparation for a cryoablation procedure; and also serves to organize and support the cryoablation needles and thermal sensors in a sterile environment; prior to use. Galil Medical is recalling 17G Cryoablation Needle Holder; FPRPR 4014. This voluntary recall has been initiated due to the possibility of excessive bioburden on the Needle Holders.
Siemens Medical Solutions USA; Inc. May-16-2012 Acuson S1000 – ACUSON S1000 ultrasound systems running software version 1.0; Siemens Medical Solutions; USA; Inc. Mountain View; CA. The product is indicated for use as an ultrasound imaging system. When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the image and the depth scale.
Varian Medical Systems; Inc. Oncology Systems May-16-2012 TrueBeam and TrueBeam STx – TrueBeam and TrueBeam STx V1.0; 1.5; 1.6.95 and below. TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy anywhere in the body where radiation treatment is indicated. Varian Medical Systems; Palo Alto; CA. Varian received a report involving a Gantry collision and is sending a notification to remind users of the collision protection tools available with TrueBeam and TrueBeam STx; including actions the operator should be aware of.
Baxter Healthcare Services L.P. May-16-2012 Coseal Surgical Sealant. – Coseal Surgical Sealant.Coseal is an adjunctive surgical sealant. The recall is being conducted as a precautionary measure due to out of specification results observed at the 24 months time point (out of 24-month licensed shelf life to expiration) during a Coseal stability study. The parameter that is out specification is an indicator of possible failure for the product to gel appropriately . Coseal’s failure to gel does not represent risk for the patient’s life
MEDDEV USA; INC. May-17-2012 50 Portal Vein Cannula – 50 Portal Vein Cannula REF 61.110.10.030 Size: Fr 10 Length: 12 Inches LL Connector LOT 120493 NON STERILE MEDDEV USA; INC. 100 Highland Park Village/Suite 200 DALLAS; TEXAS 75205For use in humans. No indication of use is on the label. However; the device can be used for infusion. The device was marketed without a 510(k) and is not sterile.
Stryker Howmedica Osteonics Corp. May-17-2012 Triathlon Navigation Tibial Alignment Handle – Tibial Alignment HandleTriathlon InstrumentsCAT #: 6541-2-807Nav Tibial Alignment Handle Triathlon InstrumentsCAT #; 6541-2-808Howmedica Osteonics Corp.325 Corporate DriveMahwah; NJ 07430The tibial alignment handles Cat# 6451-2-807 and 6541-2-808 are part of the Triathlon Knee Instruments set. The alignment handle is used after the tibial resection portion of a total knee arthroplasty procedure. The alignment handle helps holding and orienting the tibial template and trial; which are used to estimate the size and assess the orientation of the final implant. The implant will provide the new bearing surface of the knee; replacing the damaged joint. Stryker received a Product Experience Report (PER) that a swivel block was improperly oriented on a Triathlon Tibial Alignment Handle; catalog no. 6541-2-807.
Ellman International; Inc. May-17-2012 Pelleve – Pelleve Non-Ablative Wrinkle Treatment Handpiece; Product Codes D110FSHP; D115FSHP (reusable) — Pelleve — Elegance through science — Contents: One (1) Pelleve Handpiece (Reusable) — Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV. Ellman International is recalling its Pelleve reusable handpiece because of possible cable failure and sparking.
Kensey Nash Corp May-17-2012 CollaGuide Collagen Dental Membrane – a translucent; rectangular; resorbable; collagen membrane sheet derived from bovine tissue.Colla Guide Collagen Membrane Distributed by: Riemser Inc.; PO Box 12339 Research Triangle Park; NC 27709-2339 USA Kensey Nash Corporation; 735 Pennsylvania Drive; Exton; PA 19341 USA QTY 1 Sterile Rx only30mm X 40mm REF 20650-03 6280-03 Rev.AEQuantity 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30¿C (86¿F) Do not re-use.CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants; augmentation around implants placed in immediate extraction sites; augmentation around implants placed in delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects after root resection; cystectomy; removal of retained teeth; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects. Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in patient infection;
Kensey Nash Corp May-17-2012 CollaGuide Collagen Dental Membrane – a translucent; rectangular; resorbable; collagen membrane sheet derived from bovine tissue.Colla Guide Collagen Membrane Distributed by: Riemser Inc.; PO Box 12339 Research Triangle Park; NC 27709-2339 USA Kensey Nash Corporation; 735 Pennsylvania Drive; Exton; PA 19341 USA QTY 1 Sterile Rx only20mm X 30mm REF 20650-02 6280-02 Rev.AEQuantity 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30¿C (86¿F) Do not re-use.CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants; augmentation around implants placed in immediate extraction sites; augmentation around implants placed in delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects after root resection; cystectomy; removal of retained teeth; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects. Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in patient infection;
Kensey Nash Corp May-17-2012 CollaGuide Collagen Dental Membrane – a translucent; rectangular; resorbable; collagen membrane sheet derived from bovine tissue.Colla Guide Collagen Membrane Distributed by: Riemser Inc.; PO Box 12339 Research Triangle Park; NC 27709-2339 USA Kensey Nash Corporation; 735 Pennsylvania Drive; Exton; PA 19341 USA QTY 1 Sterile Rx only15mm X 20mmQuantity 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30¿C (86¿F) Do not re-use.CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants; augmentation around implants placed in immediate extraction sites; augmentation around implants placed in delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects after root resection; cystectomy; removal of retained teeth; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects. Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in patient infection;
Stryker Howmedica Osteonics Corp. May-17-2012 Cutting Edge Acetabular Spherical Reamer – Cutting Edge Acetabular Spherical Reamer 44 M; Stryker Howmedica Osteonics Howmedica Osteonics Corp. 325 Corporate Drive Mahwah; NJ 07430 USA.The CuttingEdge acetabular reamers are used to ream the acetabulum and prepare the bone for the insertion of the shell during hip arthroplasty. Surgical procedures for shells used with CuttingEdge instruments indicate that reaming should begin with a Spherical Reamer that is 4mm smaller than the templated or gauged size of the planned shell. Per the procedures; reaming should increase in size by 1mm increments until final sizing is achieved. Surgical judgment is used to assess bone stock; bone quality; desired level of press fit; and proper amount of reaming. A 46mm acetabular reamer was lasermarked as a 44m reamer and distributed to the field.
Medical Components; Inc dba MedComp May-18-2012 8F Plastic Dignity Mid-Sized CT Port – 8F Plastic Dignity Mid-Sized CT Port w/Silicone Filled Suture Holes and w/Attachable ChronoFlex Polyurethane Catheter. Catalog # MRCTI8000S. The Power Injectable; Implantable Infusion Port is an implantable single fluid reservoir port with a polyurethane (8F) catheter attachable for application by the inserting physician. 50 trays of Dignity Low Profile CT Port were labeled as Dignity Mid-Sized CT Port.
Ethicon Endo-Surgery Inc May-18-2012 The ECHELON 60 Endoscopic Linear Cutter – The ECHELON 60 Endoscopic Linear Cutter – Straight; compact ECHELON 60 Endoscopic Linear Cutter – Straight; and the Long ECHELON 60 Endoscopic Linear Cutter – Straight are sterile; single patient use instruments that deliver staples while simultaneously dividing tissue between rows. ECHELON 60 instruments with white; blue; gold; and green reloads deliver two triple-staggered rows of staples. The instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. A staple retaining cap on the reload protects the staple leg points duringshipping and transportation. Sterile products are individually packed in a transparent tray sealed with Tyvek¿. Each tray is placed in an individual carton. 3 individual cartons are placed in a corrugated shipper.The ECHELON 60 Endoscopic Linear Cutter Straight; Compact ECHELON 60 Endoscopic Linear Cutter Straight; and the Long ECHELON 60 Endoscopic Linear Cutter Straight are intended for transection; resection; and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general; gynecologic; urologic; thoracic; and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. There is a possibility of a component breakage; which may cause the device to stay locked on tissue after firing. If the component exhibits this issue; the device does not open either with the anvil release button or with the manual firing release lever.
Diamedix Corporation May-21-2012 ENA-6 Screen Enzyme Immunoassay Test Kit – Product is labeled in part: "***is immunosimplicity***ENA-6 Screen***Enzyme Immunoassay Test Kit***Catalog No: 720-230***Exp. Date: 2012-05-31***Contains Sufficient for 96 Tests***C – Corrosive Harmful***Lot No: S0000***For In Vitro Diagnostic Use***Caution; consult accompanying documents***Manufacturer DIAMEDIX***a Subsidiary of IVAX Diagnostics; Inc.***Miami; FL 33127 USA-1-800-327-4565***Biohazard***"For the qualitative screening of human IgG antibodies to extractable nuclear antigens (ENA) in human serum by indirect enzyme immunoassay as an aid in the diagnosis of certain autoimmune disorders. This test system screens for antibodies to Sm; Sm/RNP; SSA; SSB; Scl-70 and Jo-1 in one well. Positive samples should be evaluated further using tests designed for each ENA antibody. On 06/08/2011 Diamedix Corporation initiated a recall of Is-ENA-6 Screen Test Kit; Catalog # 720-320 Master Lot S0000; Exp. Date May 31; 2012. The labeling on the kit box has an expiration date of 2012-05-31 while the components have an expiration date of 2012-04-30 for an incorrect expiration date.
Arcadia Medical Corporation May-21-2012 Tracheostomy tubes – Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck Flange Tracheostomy Tube; Size 4.0 mm I.D. Catalog Number 353-040.Intended for use in providing direct tracheal access for airway management. A defect in 3 tracheostomy tubes. The defect observed was a separation in the bond between the proximal junction of the neck flange and the cannula.
Computerized Medical Systems Inc May-22-2012 XiO Radiation Treatment Planning System – XiO Radiation Treatment Planning System; Versions 4.30.00-4.64.00.Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display; both on-screen and in hard-copy; either two- or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up. XiO will underestimate the dose delivered when the closed leaf gap is set to 0mm on XiO and a value other than 0mm is set on the accelerator.
Philips Medical Systems (Cleveland) Inc May-22-2012 Ingenuity TF PET/MRI System – Ingenuity TF PET/MRI System v.3.7.1; 510(k) #K103483; Model #882380. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI). The system does not expose the patient to any ionizing radiation. The MRI Subsystem produces cross-sectional images; spectroscopy images and/or spectra in any orientation of the internal structures of the whole body. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient ‘s body (specific pharmaceuticals are used for whole body; brain; and other organ imaging). The PET and MRI portion of the system can be used either as an integrated system or as a stand-alone MRI or PET system. The MRI subsystem provides data suitable for use in attenuation correction of the PET acquired data. Software errors. A number of non-conformances were identified and corrected by Philips Medical for their Ingenuity TF PET/MRI Systems running software version 3.7.1. The firm states that these non-conformances stemmed from software and/or documentation errors; and that software corrections are being performed in order to ‘improve the overall quality and functionality of the Ingenuity TF CT/MRI S
Biosense Webster; Inc. May-22-2012 EZ STEER Catheter – EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional CatheterCardiovascular catheter for use in electrophysiological diagnosis and ablation. The recall was initiated because the catheter unit was shipped with a label expiration date of 9/30/2010; which is 11 months beyond the correct expiration date of 10/31/2009.
College Park Industries; Inc. May-23-2012 Celsus Foot – Celsus prosthetic foot; Product Number 103658-00. The Celsus is intended for low impact level lower limb prosthesis users weighing up to 300 lbs. An incorrect shorter part ( pyramid) was installed in the foot. A foot of this size and configuration requires a longer pyramid. Customers requiring the extra firm configuration may have a minimal risk of component failure; which could be implicated in a potential fall.
Captiva Spine; Inc May-23-2012 Drill Bits for Cervical Plate System – Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part Number CP40012***12mm Drill Bit***Lot Number 89427-2 R***" "***Part Number CP40014***14mm Drill Bit***Lot Number 89427-3-R***" The Captiva Spine SmartLOX Cervical Plate System is intended for the anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Captiva Spine is recalling the SmartLOX Cervical Plate components 12 & 14 mm Drill Bits; Single Barrel Variable Drill Guides; and Double Barrel Fixed Drill Guides. The components are part of the instrumentation kit used to complete an anterior screw fixation of the cervical spine. There is a potential risk for the drills to not properly fit through the drill guides due to an overlap in the dime
Captiva Spine; Inc May-23-2012 Accessories for the Captiva Spine SmartLOX Cervical Plate System. – Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part Number CP50150***Single Barrel Variable Drill Guide***Lot Number 1500705A or Lot Number 06110041***" "***Part Number CP50160***Single Barrel Fixed Drill Guide***Lot Number 1500707A or Lot Number 06110043***" "***Part Number CP50170***Double Barrel Fixed Drill Guide***Lot Number 1500708A or Lot Number 06110044***" Products are packaged individually and shipped as replacement parts to be placed in the SmartLOX Cervical Plate System tray.The Captiva Spine SmartLOX Cervical Plate System is intended for the anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Captiva Spine is recalling the SmartLOX Cervical Plate components 12 & 14 mm Drill Bits; Single Barrel Variable Drill Guides; and Double Barrel Fixed Drill Guides. The components are part of the instrumentation kit used to complete an anterior screw fixation of the cervical spine. There is a potential risk for the drills to not properly fit through the drill guides due to an overlap in the dime
Elekta; Inc. May-23-2012 Linear Accelerator – MLCi/MCLi2.Radiation therapy. The Y2 diaphragm block was found loose.
Becton Dickinson & Co. May-24-2012 BD Phoenix System software update disk – Becton Dickinson Phoenix" Update Disks (PUD); catalog # 441107/ 448047; component of BD automated microbiology system; and used with BD Gram Positive MIC or MIC/ID panels. Product Usage:This update disk was an interim corrective action recommended by FDA to be installed in Phoenix instruments so that test results associated with E.faecium susceptibility can not be printed by the labs until a final algorithm correction (change) is implemented by the firm In vitro diagnostics manufacturer identified an increase in vancomycin-resistant strains that may exhibit erroneous results on all PMIC or PMIC/ID panels and could lead to ineffective treatment regimen in affected patients.
Becton Dickinson & Co. May-24-2012 BD Phoenix Automated Microbiology System Software for Automated Microbiological System – Becton Dickinson Phoenix" System Software; catalog # 448035/448046; component of BD automated microbiology system; and used with BD Gram Positive MIC or MIC/ID panels. Product Usage:Automated Microbiology System for the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of Gram Positive bacteria from pure culture. In vitro diagnostics manufacturer identified an increase in vancomycin-resistant strains that may exhibit erroneous results on all PMIC or PMIC/ID panels and could lead to ineffective treatment regimen in affected patients.
Apheresis Technologies; Inc. May-24-2012 PlasmaPro Plasma Pump – PlasmaPrO"Plasma Pump Model PP-05Product Usage:The PlasmaPro Plasma Pump is a pump to be used with Asahi Plasma Separators to perform therapeutic plasma exchange. Apheresis Technologies; Inc.; Palm Harbor; FL; initiated a voluntarily withdrawal on November 29; 2010 of their five (5) units of the Plasma Pro Plasma Pump and later classified as a recall (removal) rather than a withdrawal; Model # PP-05; Serial Numbers: E08003041; E08003042; E08003043; E08003044 and E08003045.
Vascular Solutions; Inc. May-24-2012 GuideLiner V2 Catheter – Vascular Solutions; GuideLiner V2 Catheter; Rx only; Sterile EO; Catalog Number 5571; 6F; Vascular Solutions; Inc.; 6464 Sycamore Court; Minneapolis; MN 55369. Intended to be used in conjunction with guide catheters to access discrete regions of the coronary and or peripheral vasculature and too facilitate placement and exchange of guidewired and other interventional devices. Vascular Solutions has became aware of a potential defect with their 6F GuideLiner V2 catheters (Model 5571) with lot number 555038. Use of this product could result in the catheter shaft separating from the pushwire on the device. This may cause a procedural delay and/or injury possibly requiring medical intervention.
Cincinnati Sub-Zero Products Inc May-24-2012 Cardiopulmonary bypass temperature controllers – ECMO Heaters Model 333W; 115V – Part #86135; and 230V & 240V – Part #86136; Cardiopulmonary by-pass temperature controllers. The ECMO Heaters are used in conjunction with a heat exchanger to warm the fluid temperature. The device is composed of a heater; a circulating pump; fan; safety high limit; and a microprocessor board. Water is heated and pumped from the unit to the heat exchanger. The device can be set so that the operator can monitor the actual water temperature or; with the use of a 400 series probe; the fluid (external) temperature. This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a patient’s blood temperature. It can be used during extracorporeal circulation procedures. It is intended to use with commercially available heat exchangers. Design error. The probe jack contacts (terminals on certain of the firm’s ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with one another. If this situation occurs; a Service Technician; Operator/User; and/or Patient could be exposed to electric shock during device servicing or use. This situation was ori
Water Pik; Inc. May-25-2012 Waterpik – Water Pik Sinusense battery operated device including a blue semi-transparent water reservoir; a white hand held button initiated injector device; and a soft seal nozzle affixed to the white injector. The product is sold individually in white; blue red and orange cartons with a photo of the device as well as a stream of water flowing through it. The contents of the container include the device as well as a package insert with utilization instructions.Product Usage: Sinus washing device to keep sinus passages clear of congestion. Customer complaints related to cross contamination of sinus rinse solution between the battery compartment and solution reservoir used for rinsing nasal passages.
Ethicon Endo-Surgery Inc May-25-2012 HARMONIC Blue Hand Piece & HARMONIC Hand Piece – HPBLUE: HARMONIC¿ Blue Hand Piece; HP054: HARMONIC¿ Hand Piece; Non-Sterile products are individually packed in a poly bag and then placed into an individual carton. Mfr. By: Ethicon Endo-Surgery; LLc; 475 Calle C; Guaynbo; PR 00969.Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery; lasers; and steel scalpels. Ethicon Endo-Surgery initiated a voluntary recall due to some lot numbers of the HARMONIC? Hand Piece (HP054) and the HARMONIC? Blue Hand Piece (HPBLUE); which impacts their compatibility with the HARMONIC? Generator 300 (GEN04). The problem occurs after successful set up and initial use of HARMONIC? Hand Pieces (HP054 and HPBLUE) with the Generator 300 (GEN04). The procedure is interrupted when
Siemens Medical Solutions USA; Inc May-25-2012 Siemens MAGNETOM Essenza; Nuclear Magnetic Resonance Imaging System – Siemens MAGNETOM Essenza; Nuclear Magnetic Resonance Imaging SystemProduct Usage:Nuclear magnetic resonance imaging There is an error in the compatibility data sheet which is part of the System Owner Manual
ConMed Electrosurgery May-29-2012 Altrus Energy Source – Altrus Energy Source REF 60-9500-120 Tissue Fusion Energy Source ConMed Corporation 525 French Rd; Utica; NY 13502; MDSS GmbH; Germany. The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. An investigation of the ConMed Electrosurgery Altrus Energy Source revealed that the device could have been calibrated incorrectly resulting in error messages or delays in surgery.
Alphatec Spine; Inc. May-29-2012 Alphatec Souls Proximal/Distal Deployment Wrench – SOLUS Anterior Lumbar Interbody Fusion SpinalSpacer System; Solus Proximal/Distal Deployment Wrenches; 510(k) K102402.The Alphatec Solus Anterior Lumbar Interbody Fusion (AUF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondyiolisthesis or retrolisthesis at the involved level(s). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Alphatec Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades. The Alphatec Solus implant is intended for use with supplemental spinal fixation. Specifically; the Alphatec Solus implant is to be used with the Alphatec’s Zodiac¿ Spinal Fixation System; Aspida" Anterior Lumbar Plating System; or the ILLlCO¿ MIS Posterior Fixation System. Intervertebral body fusion device. Alphatec Spine has received several complaints (n+4) on the Alphatec Solus Distal Deployment Wrench for twisting or bending; which has been discovered either during or after instrumentation use. A fifth complaint received in which it was reported that the spline tip of the Alphatec Solus Proximal Deployment Wrench had sheared from the instrument upon use.
ConMed Electrosurgery May-29-2012 Altrus Thermal Tissue Fusion – Altrus Thermal Tissue Fusion; Tissue Fusion Handpiece 5 mm O.D.; 36 cm Shaft; Catalog Number 60-9522-001; Sterile/EO.The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding.
ConMed Electrosurgery May-29-2012 Altrus Thermal Tissue Fusion – Altrus Thermal Tissue Fusion; Tissue Fusion Handpiece 5 mm O.D.; 16 cm Shaft; Catalog Number 60-9520-001; Sterile/EO.The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding.
ConMed Electrosurgery May-29-2012 Altrus Thermal Tissue Fusion – Altrus Thermal Tissue Fusion; Tissue Fusion Handpiece 10 mm O.D.; 23 cm Shaft; Catalog Number 60-9511-001; Sterile/EO.The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding.
ConMed Electrosurgery May-29-2012 Altrus Thermal Tissue Fusion – Altrus Thermal Tissue Fusion; Tissue Fusion Handpiece 5 mm O.D.; 23 cm Shaft; Catalog Number 60-9521-001; Sterile/ EO.The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding.
Stryker Howmedica Osteonics Corp. May-29-2012 Restoration HA Reduced Neck – Restoration HA Reduced Neck 25 mm Long StemManufactured by Stryker Howmedica Osteonics Corp.325 Corporate DriveMahwah; NJ 07430.The Restoration HA cementless Hip System is designed to address the problems of revision surgery where extensive fixation both distally and proximally is required for support of the prosthesis. A comprehensive size range mates a variety of proximal cross sections and lengths with 10 distal cylindrical diameters to provide for patient matched sizing in revision circumstances. The stem design incorporates a physiologic 127 degree neck stem angle; neck length ranges and a C-Taper head to provide the surgeon with the ability to restore near anatomic head position for proper leg length and biomechanical function. Restoration HA femoral component accepts C-Taper heads; 22mm; 26mm; 28mm; and 32mm with a negative 5mm to positive 10mm offsets. An incorrect laser mark was noted on specific lots of product; incorrectly implying a stem size of 9; when the product is actually size 8.
Philips Medical Systems (Cleveland) Inc May-30-2012 Brilliance iCT and Brilliance iCT SP Computed Tomography X-Ray Scanning Systems – Brilliance iCT – Model #728306; and Brilliance iCT SP – Model #728311; CT Scanning System is subject to recall/correctionProduct Usage:The Brilliance 6; 16; 40 64; Brilliance Big Bore; iCT; iCT SP and Ingenuity CT are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment ; patient; and equipment supports; components and accessories. Component defect. Following their receipt of a customer complaint; Philips Medical determined that the metal blocks which support the scissor slide rails underneath the scanning table (couch) of several of the firm’s CT scanning systems were not manufactured to specification and may crack.
Siemens Medical Solutions USA; Inc. May-30-2012 e.cam Emission Computed Tomography Systems – e.cam Emission Computed Tomography Systems. Siemens e.cam Emission Imaging Computed Tomography Systems is used for all common nuclear medicine procedures. Siemens has identified a potential patient safety issue for e.cam and Symbia E camera systems that have had the radial drive motor assembly replaced during a Service action. There is a remote chance that during the motor replacement the radial drive gear may have been replaced incorrectly. If the gear is installed incorrectly the mechanical brake may not engage creating a patient hazard if the sys
Philips Medical Systems (Cleveland) Inc May-30-2012 Brilliance 16 Computed Tomography X-Ray Scanning System – Brilliance 16 – Model #728246; CT Scanning System is subject to recall/correctionProduct Usage:The Brilliance 6; 16; 40 64; Big Bore; iCT; iCT SP and Ingenuity CT are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment ; patient; and equipment supports; components and accessories. Component defect. Following their receipt of a customer complaint; Philips Medical determined that the metal blocks which support the scissor slide rails underneath the scanning table (couch) of several of the firm’s CT scanning systems were not manufactured to specification and may crack.
Philips Medical Systems (Cleveland) Inc May-30-2012 Brilliance iCT and iCT SP – The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment; patient; and equipment supports; components and accessories. On 3/5/2012; Philips Healthcare was notified of one incident involving a Brilliance iCT scanner that resulted in damage to the gantry and slight injury to the user when the heat exchanger detached from the cooling unit due to some missing welds.
Philips Healthcare Inc. May-30-2012 Philips Imaging – Philips Practix Convenio Mobile X-ray SystemModel: 70455The Practix Convenio is a mains independent motor driven mobile x-ray system; to x-ray body parts of patients to create images for medical diagnostic purposes. The Practix Convenio is intended to x-ray in rooms for medical use. Unexpected Low-level X-ray pulse
Siemens Medical Solutions USA; Inc. May-30-2012 Symbia E Series SPECT System – Symbia E Series SPECT System; Single-Photon Emission Computed Tomography. The Siemens Symbia E system is a high performance dual detector variable angle system with flexible patient positioning for planar imaging; whole-body scans; and SPECT studies. Siemens has identified a potential patient safety issue for e.cam and Symbia E camera systems that have had the radial drive motor assembly replaced during a Service action. There is a remote chance that during the motor replacement the radial drive gear may have been replaced incorrectly. If the gear is installed incorrectly the mechanical brake may not engage creating a patient hazard if the sys
Philips Medical Systems (Cleveland) Inc May-30-2012 Brilliance Big Bore Computed Tomography X-Ray Scanning Systems – Brilliance Big Bore – Model #728243; and – Model #728244; CT Scanning System is subject to recall/correctionProduct Usage:The Brilliance 6; 16; 40 64; Brilliance Big Bore; iCT; iCT SP and Ingenuity CT are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment ; patient; and equipment supports; components and accessories. Component defect. Following their receipt of a customer complaint; Philips Medical determined that the metal blocks which support the scissor slide rails underneath the scanning table (couch) of several of the firm’s CT scanning systems were not manufactured to specification and may crack.
Philips Medical Systems (Cleveland) Inc May-30-2012 Brilliance 40 and Brilliance 64 and Ingenuity Computed Tomography X-Ray Scanning Systems – Brilliance 40 – Model #72835; and Brilliance 64 – Model #728231; and Ingenuity – Model #728326; CT Scanning Systems are subject to recall/correctionProduct Usage:The Brilliance 6; 16; 40 64; Big Bore; iCT; iCT SP and Ingenuity CT are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment ; patient; and equipment supports; components and accessories. Component defect. Following their receipt of a customer complaint; Philips Medical determined that the metal blocks which support the scissor slide rails underneath the scanning table (couch) of several of the firm’s CT scanning systems were not manufactured to specification and may crack.
CaridianBCT; Inc. May-30-2012 Terumo BCT – Terumo BCT Lakewood; CO 80215; Catalog No 61000 Spectra Optia Apheresis System; Country of Origin: US.Product Usage:For use in humans. Within the US marketplace; this device is approved for use in Therapeutic Plasma Exchange. Internationally; this device is approved for use in Mono Nucleo Cell engraftment. Defective product may result in decreased efficacy.
Siemens Medical Solutions USA; Inc. May-30-2012 Siemens brand ACUSON S2000 Ultrasound Systems; and the Advanced SieClearTM spatial – Siemens brand ACUSON S2000 Ultrasound Systems; and the Advanced SieClearTM spatialcompounding feature Software Versions 3.0; 3.0A and 3.1. (VB20; VB20A; and VB21A);Model #: 10440017 – ACUSON S2000 Refurb. Mainframe; Product is manufactured and distributed by Siemens Medical Solutions USA; Inc.; Mountain View; CAThe ACUSON S2000 Ultrasound System is a multi-purpose mobile; software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode; M-Mode; Pulsed (PW) Doppler Mode; Continuous (CW) Doppler Mode; Color Doppler Mode; Amplitude Doppler Mode; a combination of modes; or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display. The ACUSON S2000 ultrasound imaging systems are intended for the following applications: Fetal; Abdominal; Intraoperative; Pediatric; Small Parts; Transcranial; OB/GYN; Cardiac; Pelvic; Neonatal/Adult Cephalic; Vascular; Musculoskeletal; Superficial Musculoskeletal; and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal; abdominal; intraoperative; intraoperative neurological; pediatric; small organ; neonatal cephalic; adult cephalic; cardiac; trans-esophageal; transrectal; transvaginal; peripheral vessel; musculoskeletal (conventional); musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the image and the depth scale.
Siemens Medical Solutions USA; Inc. May-30-2012 Siemens brand ACUSON S2000 Ultrasound Systemsand the Advanced SieClearTM spatial; – Siemens brand ACUSON S2000 Ultrasound Systems; and the Advanced SieClearTM spatialcompounding feature Software Versions 3.0; 3.0A and 3.1. (VB20; VB20A; and VB21A); Model #: 10041461 – ACUSON S2000 Mainframe; Product is manufactured and distributed by Siemens Medical Solutions USA; Inc.; Mountain View; CAThe ACUSON S2000 Ultrasound System is a multi-purpose mobile; software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode; M-Mode; Pulsed (PW) Doppler Mode; Continuous (CW) Doppler Mode; Color Doppler Mode; Amplitude Doppler Mode; a combination of modes; or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display. The ACUSON S2000 ultrasound imaging systems are intended for the following applications: Fetal; Abdominal; Intraoperative; Pediatric; Small Parts; Transcranial; OB/GYN; Cardiac; Pelvic; Neonatal/Adult Cephalic; Vascular; Musculoskeletal; Superficial Musculoskeletal; and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal; abdominal; intraoperative; intraoperative neurological; pediatric; small organ; neonatal cephalic; adult cephalic; cardiac; trans-esophageal; transrectal; transvaginal; peripheral vessel; musculoskeletal (conventional); musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the image and the depth scale.