February Summary
Class I recalls: 30
Class II recalls: 170

Class I recalls

Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall

Tandem Diabetes Care Inc           Feb-10-2014       "Insulin Infusion Pump – Product trade name  t:slim"" Insulin Delivery System Generic name  Insulin Infusion Pump                                                                     510(k) Number K111210 cleared on Nov. 9; 2011Description of the product – The Tandem t:slim"" Insulin Delivery System (t:slim System or t:slim) is an Insulin Infusion Pump; product code LZG; per 21 CFR 880.5725.  The t:slim System consists of the following components and accessories: (1) a software-controlled; programmable insulin infusion pump (t:slim Pump) capable of both basal and bolus delivery of insulin; (2) a dedicated; disposable 3mL (300 unit) insulin cartridge; (3) UnoMedicals Comfort"" Infusion Set (K051264); or an equivalently cleared set; and (4) additional device accessories including a Becton Dickinson 3mL sterile syringe and 26 gauge sterile needle; or equivalently cleared syringe and needle; as well as an AC power supply with USB for charging the Pumps internal battery; cartridge Instructions for Use; and Users Guide."             Tandem Diabetes Care; Inc. announced that it is initiating a voluntary recall of specific lots of insulin cartridges that are used with the t:slim Insulin Pump.  The affected cartridges may be at risk for leaking.  The cause of the recall was identified during Tandems internal product testing; and has not been associated with any complaints or adverse events reported by customers.  However; a c

Merit Medical Systems; Inc.        Feb-20-2014       Merit Medical’s Custom Procedural Trays – Merit Medical’s Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection; USP; 10 mg/mL; Lot 25-090-DK.  Custom Procedural Tray or kit is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product’s intended uses.Custom procedural trays or kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product’s intended uses.  Custom Procedural Trays/Kits contain 1% Lidocaine HCl injection which were recalled because one confirmed customer report where visible particulate were found in the primary product container in the form of dark red/black particles. The particular matter may dislodged through the tissue and could possibly cause a pneumothorax or hemothorax.

Teleflex Medical               Feb-21-2014       ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet; 6.0; Rx o – ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet; 6.0; Rx only; Product Usage:A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.      The tracheal tube can kink during patient use.

Teleflex Medical               Feb-21-2014       ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port; 7.0; – ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port; 7.0; Rx only;Product Usage:A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.        The tracheal tube can kink during patient use.

Teleflex Medical               Feb-21-2014       ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port; 8.5; Rx only; – ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port; 8.5; Rx only; Product Usage:A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.      The tracheal tube can kink during patient use.

Teleflex Medical               Feb-21-2014       ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port; 9.0; Rx only – ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port; 9.0; Rx only; Product Usage:A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.      The tracheal tube can kink during patient use.

Teleflex Medical               Feb-21-2014       ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet; 7.5; Rx o – ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet; 7.5; Rx only; Product Usage:A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.      The tracheal tube can kink during patient use.

Teleflex Medical               Feb-21-2014       ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet; 9.0; Rx o – ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet; 9.0; Rx only; Product Usage:A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.      The tracheal tube can kink during patient use.

Teleflex Medical               Feb-21-2014       ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port; 8.0; Rx only – ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port; 8.0; Rx only; Product Usage:A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.      The tracheal tube can kink during patient use.

Teleflex Medical               Feb-21-2014       ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet; 6.5; Rx o – ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet; 6.5; Rx only; Product Usage:A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.      The tracheal tube can kink during patient use.

Teleflex Medical               Feb-21-2014       ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port; 7.5; – ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port; 7.5; Rx only; Product Usage:A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.      The tracheal tube can kink during patient use.

Teleflex Medical               Feb-21-2014       ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet; 7.0; Rx o – ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet; 7.0; Rx only; Product Usage:A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.      The tracheal tube can kink during patient use.

Teleflex Medical               Feb-21-2014       ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet; 8.0; Rx o – ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet; 8.0; Rx only; Product Usage:A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.      The tracheal tube can kink during patient use.

Teleflex Medical               Feb-21-2014       ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port; 6.5; – ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port; 6.5; Rx only; Product Usage:A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.      The tracheal tube can kink during patient use.

Teleflex Medical               Feb-21-2014       ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port – ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port; 6.0; Rx only; Product Usage:A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.      The tracheal tube can kink during patient use.

Teleflex Medical               Feb-21-2014       ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet; 8.5; Rx o – ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet; 8.5; Rx only; Product Usage:A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.      The tracheal tube can kink during patient use.

Medline Industries; Inc.                Feb-21-2014       ANGIO PACK #2 – ANGIO PACK #2; REF: DYNJ39185; Packaged in Mexico by: Medline Industries; Inc.; Mundelein; IL 60060; 1-800-Medline; www.medline.comSurgical kit used to supply tools required to perform angiography medical procedures.     Guidewire .035×150 3MMJ TCFC; item number 88241; has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries; Inc.

Medline Industries; Inc.                Feb-21-2014       CATH TRAY – CATH TRAY; REF: DYNJ41101; Packaged in Mexico by: Medline Industries; Inc.; Mundelein; IL 60060; 1-800-Medline; www.medline.comSurgical kit used to supply tools required to perform angiography medical procedures.           Guidewire .035×150 3MMJ TCFC; item number 88241; has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries; Inc.

Medline Industries; Inc.                Feb-21-2014       CATH LAB CUSTOM PACK – CATH LAB CUSTOM PACK; REF: DYNJ40926; Packaged in Mexico by: Medline Industries; Inc.; Mundelein; IL 60060; 1-800-Medline; www.medline.comSurgical kit used to supply tools required to perform angiography medical procedures.    Guidewire .035×150 3MMJ TCFC; item number 88241; has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries; Inc.

Medline Industries; Inc.                Feb-21-2014       CATH PACK – CATH PACK; REF: DYNJ41103; Packaged in Mexico by: Medline Industries; Inc.; Mundelein; IL 60060; 1-800-Medline; www.medline.comSurgical kit used to supply tools required to perform angiography medical procedures.           Guidewire .035×150 3MMJ TCFC; item number 88241; has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries; Inc.

Medline Industries; Inc.                Feb-21-2014       ANGIOGRAPHY PACK – ANGIOGRAPHY PACK; REF: DYNJ26855D; Packaged in Mexico by: Medline Industries; Inc.; Mundelein; IL 60060; 1-800-Medline; www.medline.comSurgical kit used to supply tools required to perform angiography medical procedures.        Guidewire .035×150 3MMJ TCFC; item number 88241; has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries; Inc.

Medline Industries; Inc.                Feb-21-2014       STERILE SAMPLE CATH LAB PACK – STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries; Inc.; Mundelein; IL 60060; 1-800-Medline; www.medline.comSurgical kit used to supply tools required to perform medical procedures.              Guidewire .035×150 3MMJ TCFC; item number 88241; has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries; Inc.

Medline Industries; Inc.                Feb-21-2014       STERILE SAMPLE BUILD – STERILE SAMPLE BUILD; REF: SAMP0147; Packaged for Medline Industries; Inc.; Mundelein; IL 60060; 1-800-Medline; www.medline.comSurgical kit used to supply tools required to perform medical procedures.             Guidewire .035×150 3MMJ TCFC; item number 88241; has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries; Inc.

Medline Industries; Inc.                Feb-21-2014       CATH PACK – CATH PACK; REF: DYNJ40904; Packaged in Mexico for Medline Industries; Inc.; Mundelein; IL 60060; 1-800-Medline; www.medline.comSurgical kit used to supply tools required to perform medical procedures.     Guidewire .035×150 3MMJ TCFC; item number 88241; has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries; Inc.

Medline Industries; Inc.                Feb-21-2014       CATH ANGIOGRAPHY DRAPE PACK – CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline Industries; Inc.; Mundelein; IL 60060; 1-800-Medline; www.medline.comSurgical kit used to supply tools required to perform medical procedures.      Guidewire .035×150 3MMJ TCFC; item number 88241; has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries; Inc.

Medline Industries; Inc.                Feb-21-2014       HEART CATH CUSTOM PACK – HEART CATH CUSTOM PACK; REF: DYNJ39747A; Packaged in Mexico by: Medline Industries; Inc.; Mundelein; IL 60060; 1-800-Medline; www.medline.comSurgical kit used to supply tools required to perform angiography medical procedures.            Guidewire .035×150 3MMJ TCFC; item number 88241; has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries; Inc.

Medline Industries; Inc.                Feb-21-2014       STERILE SAMPLE BUILD – STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries; Inc.; Mundelein; IL 60060; 1-800-Medline; www.medline.comSurgical kit used to supply tools required to perform medical procedures..           Guidewire .035×150 3MMJ TCFC; item number 88241; has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries; Inc.

GE Healthcare; LLC          Feb-25-2014       Giraffe and Panda Bag and Mask Resuscitation System – GE Healthcare – Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System.  Product Usage:The Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care.      Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.

GE Healthcare; LLC          Feb-25-2014       Emergency Powered Ventilator Resusicitator – GE Healthcare – Giraffe and Panda iRes Infant WarmerProduct Usage:The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonates transition to the external environment or to provide a controlled open environment. An optional integrated Sp02 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate.        Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.

GE Healthcare; LLC          Feb-25-2014       Giraffe and Panda Warmer T-Piece Resuscitation System – GE Healthcare – Giraffe Warmer;Panda Warmer;Panda iRes Warmer; Giraffe Stand-alone Infant Resuscitation System. Product Usage:The T-Piece Resuscitation System [ventilator; emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care.              Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.

Class II recalls

Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall

Fresenius Medical Care Holdings; Inc.     Feb-03-2014       Fresenius Bicarbonate Jug Adapter – Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machinePart Number: 650103.The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container.                Bicarbonate Jug Adapter distributed  prior to510(k) approval

AGFA Corp.        Feb-03-2014       IMPAX RIS QDOC 5.8 and higher – IMPAX RIS QDOC 5.8  Patient name displayed (printed) on the Patient Report was the  wrong patient name.

B. Braun Medical; Inc.    Feb-03-2014       B. Braun – B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 MLGenerally used for delivery of antibiotic and local anesthesia medications.                Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion of medications.

GE Healthcare   Feb-03-2014       Stand-Alone Resuscitation Unit; Bag and Mask – Stand-Alone Resuscitation Unit; Bag and Mask; part number M1226444; labeled in part ***GE Healthcare 8880 Gorman Road Laurel; MD 20723***www.gehealthcare.com***.Provides the basic equipment required for pulmonary resuscitation of infants.                Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.

Highland Metals; Inc.      Feb-03-2014       SuperElastic Regular force NiTi lower or upper Natural arches. – SuperElastic Regular force NiTi lower or upper Natural arches.0.16 size10 or 100 count packages.Highland Metals Inc.San Jose; CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.  Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark.

Highland Metals; Inc.      Feb-03-2014       SuperElastic Regular force NiTi lower or upper Natural arches. – SuperElastic Regular force NiTi lower or upper Natural arches.0.14 size10 or 100 count packages.Highland Metals Inc.San Jose; CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.  Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark.

GE Healthcare   Feb-03-2014       Giraffe Infant Warmers – Giraffe Infant Warmers; part number M1118179; labeled in part *** GE Healthcare 8880 Gorman Road Laurel; MD 20723***www.gehealthcare.com*Giraffe Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.                Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.

GE Healthcare   Feb-03-2014       Panda iRes Infant Warmers – Panda iRes Infant Warmers; part number M1112198 and Panda Freestanding Warmers; part number 2063568; labeled in part *** GE Healthcare 8880 Gorman Road Laurel; MD 20723***www.gehealthcare.com**Panda Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.  Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.

GE Healthcare   Feb-03-2014       Upgrade Kit; Resuscitation; T-Piece – Upgrade Kit; Resuscitation; T-Piece; part numbers M1139417; M1192226 and M1223628; labeled in part ***GE Healthcare 8880 Gorman Road Laurel; MD 20723 ***www.gehealthcare.com***Provides the basic equipment required for pulmonary resuscitation of infants. Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.

GE Healthcare   Feb-03-2014       Stand-Alone Resuscitation Unit; Bag and Mask – Stand-Alone Resuscitation Unit; Bag and Mask; Upgrade Kits; part number M1139612; labeled in part ***GE Healthcare 8880 Gorman Road Laurel; MD 20723***www.gehealthcare.com***Provides the basic equipment required for pulmonary resuscitation of infant.s                Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.

GE Healthcare   Feb-03-2014       Stand-Alone Resuscitation; T-Piece – Stand-Alone Resuscitation; T-Piece; part numbers 2063771-001; 2063772-001; 2063773-001; 2063774-001; 2063775-001; M1226442; M1241420; M1241421; M1241424; M1241425; M1241427; M1241430; M1241461; M1241463; M1241464; and M1241589; labeled in part ***GE Healthcare 8880 Gorman Road Laurel; MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants.                Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.

Exactech; Inc.    Feb-03-2014       InteGrip Acetabular Augment – ***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH; Gainesville; FL 32653-1630.The Exactech Novation InteGrip Acetabular Augments are indicated for use in skeletally mature individuals undergoing primary or revision surgery for hip replacement and whose orthopedic surgeon desires a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.          Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard.

GE Healthcare; LLC          Feb-03-2014       Precision 500D R&F X-ray System – GE Healthcare Precision 500D; Precision MPI & Precision RXI X-ray imaging systems.The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations; including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body; skull; spinal column; chest; abdomen; extremities; and other body parts. Applications can be performed with the patient sitting; standing; or lying in the prone or supine position.      GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D; Precision MPI & Precision RXI X-ray imaging systems overhead LCD Video Monitor Suspension (Single monitor & Dual monitor).There is a potential for the locking nut to loosen out of the LCD Video Monitor Suspension yoke. This will not lead to an immediate fall of the suspended monitor since it will

Edwards Lifesciences; LLC            Feb-03-2014       Crimper – Crimper Model 9100CR26The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.         Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they may not open sufficiently when the handle isrotated in the full open position. As a result; user may have difficulty fitting a 26mm Sapien transcatheter heart valve into the crimper orifice when preparing the valve for crimping.

CareFusion 303; Inc.        Feb-03-2014       SmartSite Needleless Connector – SmartSite Needleless Connector; Model No. 2000E The SmartSite Needleless Connectors are sterile; individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line without the use of a needle.      CareFusion is recalling the SmartSite Needlefree Connector; model number 2000E; because of connection issues.  The affected SmartSite connector lots may unintentionally disconnect from a female luer; may be difficult to disconnect from a female luer; or may fail to disconnect from a female luer once attached.  Leakage may also be observed if the connector disconnects from the female luer during in

Medtronic Cardiovascular Surgery-the Heart Valve Division          Feb-03-2014       Model 7305- Mosaic Aortic Obturator – Product Name: Model 7305- Mosaic Aortic ObturatorThe Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.  Medtronic; Inc. initiated a recall of Medtronic Mosaic Aortic Obturator Model 7305 used with the Mosaic Porcine Aortic Bioprosthesis; Model Number 305;because of higher-than-expected transvalvular gradients occurring post implant.

Siemens Medical Solutions USA; Inc        Feb-03-2014       Siemens SOMATOM Definition; Definition AS; Definition Flash;  and Definition Edge – Siemens SOMATOM Definition; Definition AS; Definition Flash;  and Definition Edge systems.X-ray tomography; computed; radiology.         During clinical operation; a malfunction may occur causing a system display freeze with SOMATOM Definition; Definition AS; and definition Edge while running software version syngo CT2012 B and syngo CT2013B.

Nipro Diagnostics; Inc.   Feb-03-2014       MooreMedical Supporting Health & Care…MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Pa – MooreMedical Supporting Health & Care…MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEbalance. Manufactured by: NIPRO DIAGNOSTICS; Fort Lauderdale; FL 33309 U.S.A.Is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm.                Manufactured with an incorrect factory set unit of measure.

Nipro Diagnostics; Inc.   Feb-03-2014       MooreMedical Supporting Health & Care…MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Pa – MooreMedical Supporting Health & Care…MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by: NIPRO DIAGNOSTICS; Fort Lauderdale; FL 33309 U.S.A.Is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm.        Manufactured with an incorrect factory set unit of measure.

CareFusion 303; Inc.        Feb-04-2014       Trifuse Extension Sets – Trifurcated Extension Set; model no. ME 1224.Trifurcated Extension Set; model no. MP 9230.          CareFusion is recalling the Trifurcated Extension Set; models ME 1224 and MP 9230; because they may have a defect in the trifurcated component that could result in a component leak.

Siemens Healthcare Diagnostics; Inc        Feb-04-2014       ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN)  6-pack – ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN)  6-packSMN 10314977For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems            ADVIA Centaur Systems Phenytoin Calibrator N; lots CN58 and higher; change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calibrator N lots.

Siemens Healthcare Diagnostics; Inc        Feb-04-2014       ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 2-pack – ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 2-packSMN 10311391For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems            ADVIA Centaur Systems Phenytoin Calibrator N; lots CN58 and higher; change in recovery observed with the ADVIA Centaur Systems Phenytoin assay compared to recoveries using previous Calibrator N lots.

GE Healthcare; LLC          Feb-04-2014       CARESCAPE Monitor B850 – CARESCAPE Monitor B850; a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility.Product Usage:  The CARESCAPE Monitor B850 is intended for use on adult; pediatric; and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG; ST Segment; Arrhythmia Detection; ECG Diagnostic Analysis and Measurement; Invasive Pressure; Noninvasive Blood Pressure; Pulse Oximetry; Cardiac Output; Temperature; Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation)); Airway Gases (Fi/Et C02; 02; N20 and Anesthetic Agent); Spirometry; Gas Exchange (02 Consumption (VO2); C02 production (VCO2); energy expenditure (BE); and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG); Entropy; Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms; trends; snapshots and events; and calculations and can be connected to displays; printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner; or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner; the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel.           There is a potential for communication loss associated with the F5-01 Frame when connected to CARESCAPE Patient Data Module (PDM) in the CARESCAPE Monitor B850.  The PDM patient parameter acquisition module can sometimes spontaneously lose the communication with the host patient monitor when attached to the F5-01 Frame due to an issue with the PDM Ethernet communication hardware.  The communicatio

Elekta; Inc.          Feb-04-2014       XiO RTP System – XiO RTP System.Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. When bolus is present; the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect.

Philips Medical Systems (Cleveland) Inc Feb-04-2014       GEMINI LXL GEMINI TF PET/CT16 GEMINI TF PET/CT 64 – Diagnostic imaging systems (GEMINI LXL Model #882412; TruFlight Select Model #882438; GEMINI TF PET/CT16 Model #882470; GEMINI TF PET/CT 64 Model #882471; GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476) The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete and will not allow the PET acquisition to begin; resulting in an unexpected incomplete study.

ArjoHuntleigh Inc.           Feb-04-2014       Rotoprone Therapy System – The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning.Product Usage:  Use of the Rotoprone Therapy System is indicated for patients with severe acute respiratory distress syndrome (ARDS). These are critical patients who are at higher risk of cardiac arrest and mortality. Placing a patient in the prone position may reopen collapsed airways and thus improve pulmonary gas exchange and respiratory mechanics.  The lock pin can become stuck in the "in" position during the manual rotation; resulting in the inability to prone a patient

Stryker Medical Division of Stryker Corporation Feb-05-2014       Gaymar Medi-Therm – The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket(s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling the patient. Accessory YSI 400 series patient probe interfaces between theMedi-Therm and patient to sense patient temperature; which is displayed on the device’s control panel. The Medi-Therm device controls output water temperature by mixing hot and cold water using hot and cold solenoid valves under microprocessor control. The device includes a circulating pump; heater and refrigeration system.The Medi-Therm controller; connector hose; blanket/body wrap and patient probe comprise the Medi-Therm Hyper/Hypothermia System.              Stryker Medical has identified that on some units of the MTA7900;  there is a lack of a water temperature display while the unit is in Auto mode. While in Auto mode; only the patient temperature is displayed along with the set point. The water display will be blank during Auto mode. If the user wants to see the water temperature displayed and switches out of Auto mode to Manual mode; then back to

OrthoPediatrics Corp      Feb-06-2014       3.5mm Locking Cortical Bone Screw; T15 Hexalobe; Self Tapping; 20mm – 3.5mm Locking Cortical Bone Screw; T15 Hexalobe; Self Tapping; 20mmPart No. 00-0903-2620OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures; osteotomies; and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone Screw designed for use with this system.            OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620; 3.5MM Locking CorticalScrew; Lot # 009SV because the device within the package may be incorrect.  These packages incorrectly contain a 3.5mm Non Locking Cortical Screw # 00-1050-3524.

ITC-Nexus Dx     Feb-06-2014       International Technidyne Corporation – Hemochron Jr. Citrate APTT Cuvette510(k) K014008A unitized microcoagulation test intended to be used in performing a quantitative; one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL); depending upon individual patient heparin sensitivity.          ITC  has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals.

Zest Anchors LLC              Feb-06-2014       LOCATOR Implant Attachment System – LOCATOR Implant Attachment System.The LOCATOR Implant Attachment System is a universal hinge; resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures; retained in whole or in part; by endosseous implants in the mandible or maxilla.FDA 510(k): K994257; K072878   Zest Anchors; LLC is voluntarily recalling specific lots of LOCATOR Implant Attachment Systems because it is currently provided with a label that indicates that the final torque applied to the abutment should be 30 N-cm. It was recently noted by Zest that in order to provide an optimal performance by  increasing the factor of safety between the failure load of the abutment screw and the recommend

Ossur Americas; Inc.       Feb-06-2014       SYMBIONIC LEG – The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT; both already existing products from ssur. Both are a battery powered micro-processor controlled prosthetic device and are connected through a shared battery. The knee and the foot have different sensor systems that provide real-time information used to control knee joint resistance and the flexion/extension of the ankle during the gait cycle. Default control parameters are provided with the device but can be manually adjusted by a certified prosthetist through software (knee); or by a certified prosthetist or the user through controls on the device itself (foot).      SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25  30 and less than 100kg for foot Categories 22; 23 and 24. The system is not intended for athletic use.            OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics.

RTI Surgical;  Inc.               Feb-07-2014       OPTEFORM Allograft Paste – ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc; bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation.  ***Rx Only***Distributor: EXACTECH 2320 NW 66th Court; Gainesville; FL 32653 USA***Manufacturer: RTI Biologicals; Inc. 11621 Research Circle; Alachua; FL 32615 USA. RTI Surgical; Inc. of Alachua; FL is recalling their OPTEFORM Allograft Paste; 5cc as it may contain a 10 cc fluid dispenser. The 10cc fluid dispenser does not include the correct fluid fill line reference for reconstitution of 5cc past allografts.

Integra LifeSciences Corp.            Feb-07-2014       Malibu Polyaxial Screwdriver – Malibu Polyaxial Screwdriver; 8.0 Plus; Model Number 91-2109;Malibu Polyaxial Screwdriver; Standard; Model Number 91-2110.510(k):91-2109  K061342.91-2110  K051942.     The Malibu" System is intended to be used as a temporary or permanent posterior; non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The System is comprised of single use pedicle screws of varying reduction height; rods; rod connectors; etc. and an accompanying set of reusable surgical instruments. Some of the surgical instruments are specific to the system and others are general surgical instruments. The polyaxial screwdriver is specific to the polyaxial screws in the system.         Integra LifeSciences has identified through an investigation of complaints that there may be the potential for the shaftof the Malibu Polyaxial Drivers to break during use. None of the complaints reported a patientinjury. However; some complaints did indicate the surgery was slightly prolonged while the additional driver providedin the kit was retrieved and used.

Ortho-Clinical Diagnostics             Feb-09-2014       enGen Laboratory Automation System – enGen Track System with enGen Custom v3.2.2 (& below)Product The VITROS 5;1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest; using both VITROS Chemistry Products Slides (colorimetric endpoint; rate; ion-selective electrode; and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.                Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen Select V5.0 & enGen Custom v3.2.2 due to an anomaly that affects the autoverification feature and custom rules that depend upon data elements used by the referenced enGen Systems.

Ortho-Clinical Diagnostics             Feb-09-2014       enGen Laboratory Automation System – enGen Track System with enGen Select v5.0 with autoverification enabledProduct The VITROS 5;1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest; using both VITROS Chemistry Products Slides (colorimetric endpoint; rate; ion-selective electrode; and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.               Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen Select V5.0 & enGen Custom v3.2.2 due to an anomaly that affects the autoverification feature and custom rules that depend upon data elements used by the referenced enGen Systems.

Siemens Healthcare Diagnostics; Inc.      Feb-09-2014       Siemens ADVIA – Siemens ADVIA Chemistry Systems models 1200; 1650; 1800 and 2400Product  Usage:The ADVIA Chemistry Systems models 1200; 1650; 1800 and 2400 (also known as Clinical Chemistry Systems) are high throughput instruments which perform assays for general and specialty chemistries; methods for specific protein measurement; drugs-of-abuse testing and therapeutic drug monitoring.       The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC).

Neuro Kinetics; Inc.         Feb-10-2014       Normative Data Template CD – Normative Data Template CD for use with the I-Portal devices.Used to measure; record; or visually display the involuntary movements (nystagmus) of the eyeball.        The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k) notification process.

Brainlab AG        Feb-10-2014       BrainLAB’s VectorVision spine – BrainLAB’s VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe; tracked by a passive marker sensor system to virtual computer image space on a patient’s preoperative image data that is processed by a VectorVision workstation.The system is indicated for any medical condition in which the use of stereoscopic surgery may be appropriate and where a reference to a rigid anatomical structure; such as the skull; the pelvis; a long bone or vertebra can be identified relative to a CT; x-ray; or MR-based model of the anatomy.      Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with specific serial numbers might have been made of an incorrect material that is not suitable for the necessary disinfection and sterilization of the product. If corrosion occurs and is not detected by the user; and the device is used during surgery; corroded particles of the pin could; directly or indirect

Stryker Howmedica Osteonics Corp.       Feb-10-2014       Stryker Orthopaedics – Stryker Orthopaedics Navigation Compatible Accolade Broach Handle1 single unit to a packageHowmedica Osteonics Corp. 325 Corporate Drive Mahwah; NJ 07430 USAStryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex FranceMade in USAnon-sterile                Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.

Ortho-Clinical Diagnostics             Feb-10-2014       VITROS 250/350 Mixing Cup Array – VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry SystemsProduct Usage:Mixing Cup Array is a disposable; intermediate container used in making automatic (auto)-dilutions on the VITROS 250/350 Chemistry Systems. The VITROS 250 Chemistry System is intended for use in the in vitro quantitative; semi quantitative; and qualitative measurement of a variety of analytes of clinical interest; using VITROS Chemistry Products Microslides. The VITROS 350 Chemistry System is intended for use in the in vitro quantitative; semi quantitative; and qualitative measurement of a variety of analytes of clinical interest; using VITROS Chemistry Products MicroSlides.   Ortho Clinical Diagnostics issued a product correction notification for VITROS Chemistry Mixing Cup Arrays utilized on VITROS 250  and VITROS 350 Chemistry Systems.  Increase in Software error due to affected Mixing Cup Arrays.

Ecolab Inc            Feb-10-2014       ULTRASOUND PROBE COVER; BUR HOLE COVER – Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER; BUR HOLE COVER; 5 x 96; REF VPC0699; STERILE EO; QTY 20; Manufactured for Vital Care Reps; Inc.; Tinley Park; Illinois        Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.

Ecolab Inc            Feb-10-2014       BUR HOLE LATEX PROBE COVER WITH GEL – MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL; featuring IsoSilk(R); 5" x 98"; (13cm x 249 cm); REF 3688; STERILE EO; QTY 20; Microtek Medical; Inc.; Columbus; MS  39702     Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.

Ecolab Inc            Feb-10-2014       BUR HOLE LATEX FREE PROBE COVER – MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER; featuring IsoSilk(R); 13cm x 244 cm; 5" x 96"; REF PC3688N; QTY 100; Microtek Medical; Inc.; Columbus; MS  39702.   Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.

Ecolab Inc            Feb-10-2014       BUR HOLE LATEX FREE PROBE COVER WITH GEL – MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL; featuring IsoSilk(R); 13cm x 244 cm; 5" x 96"; REF PC3688; STERILE EO; QTY 20; Microtek Medical; Inc.; Columbus; MS  39702         Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.

Ecolab Inc            Feb-10-2014       BUR HOLE LATEX FREE PROBE COVER WITH GEL – MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL; featuring IsoSilk(R); 13cm x 244 cm; 5" x 96"; REF PC3688EU; STERILE EO; QTY 20; Microtek Medical; Inc.; Columbus; MS  39702         Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.

Ecolab Inc            Feb-10-2014       BUR HOLE LATEX PROBE COVER WITH GEL – MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL; featuring IsoSilk(R); 13cm x 249 cm; REF 3688UK; STERILE EO; QTY 20; Microtek Medical; Inc.; Columbus; MS  39702     Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.

Sysmex America; Inc.     Feb-10-2014       Sysmex UF-1000i Automated Urine Particle Analyzer with Urinalysis WAM – The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy; so it increases automation and efficiency in laboratories.                The current Century Break patch did not contain the same setting for the Century Break year for both the Red Hat Linux and GUI files. Due to the mismatch in file settings; the software could not properly calculate a purge date for the database files based on the customer data retention setting in the application. This resulted in the database files meeting its maximum capacity and causing system p

Boston Scientific Corporation     Feb-11-2014       Coyote MONORAIL PTA Balloon Dilatation Catheter – Boston Scientific; Coyote" MONORAIL" PTA Balloon Dilatation Catheter; UPN # H74939185201510; Catalogue # 39185-20151.           Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. To date; Boston Scientific has received three complaints for this issue. T

Boston Scientific Corporation     Feb-11-2014       2.5mm Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter – Boston Scientific; 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter; UPN#  H74939186251210; Catalog # 39186-25121.                Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. To date; Boston Scientific has received three complaints for this issue. T

Stryker Howmedica Osteonics Corp.       Feb-12-2014       Stryker CMF Customized Implant Kit – Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp.325 Corporate Drive; Mahwah; NJ 07430 USA.Designed individually for each patient to correct trauma and/or defects in mandibular; maxillofacial; or craniofacial bone.            Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital.

Custom Medical Specialties; Inc.               Feb-12-2014       5 x 93 US Probe Cover CMS-6049 – 5 x 93 US Probe Cover CMS-6049; Sterile; Single Patient Use. Custom Medical Specialties; Inc.; Pine Level; NC; Federal (USA) law restricts this device to the sale by or on the order of a physician.Probe cover            No endotoxin (LAL) testing to proper level.

Medtronic Sofamor Danek USA Inc          Feb-12-2014       Medtronic GRAFTON (R) DBM; Flex 2.5cm x 10cm; REF T42100 – Medtronic GRAFTON (R) DBM; Flex 2.5cm x 10cm; REF T42100; Rx only; STERILE A; QTY: 1 EA; Medtronic Sofamor Danek; USA; Inc.; 1800 Pyramid Place; Memphis; TN  38132Orthopaedic – filler; bone void             Product was labeled as being measured as 2.5 cm x 10 cm; but contained product that measured as 2.5 cm x 5 cm.

Mckesson Information Solutions LLC       Feb-12-2014       Horizon Medical Imaging; Picture Archive Communication System (PACS). – Horizon Medical Imaging; Picture Archive Communication System (PACS).         Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being displayed for a study following retrieval from archive.

Philips Medical Systems (Cleveland) Inc Feb-12-2014       GEMINI TF Big Bore PET/CT; Computed Tomography System – GEMINI TF Big Bore PET/CT; Computer Tomography System; Philips Healthcare System; Cleveland; OH  The TF Big Bore patient table experienced mechanical binding during horizontal table motion resulting in an automatic Emergency Stop (E-stop).  An E-Stop will interrupt a current scan; resulting in an incomplete study.

GE Healthcare; LLC          Feb-14-2014       GE Healthcare; Dash 3000; Dash 4000 and Dash 5000 Patient Monitors; Dash Port2 Docking Station. – GE Healthcare; Dash 3000; Dash 4000 and Dash 5000 Patient Monitors; Dash Port2 Docking Station.      GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor and Dash Port 2 Docking Station:DASH: 1. Dash stops communicating on the Unity Network resulting in Loss of Monitoring at the CARESCAPE" CIC Pro Central Station*.2. Dash displays distorted ECG waveforms in combination monitoring mode. 3. Dash incorrectly becomes Time Master on the Unity Network.4.

Invivo Corporation          Feb-14-2014       Expression Information Portal (IP5) – Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit; where the device monitors the vital signs of a patient undergoing an MRI procedure from the MR control room; induction room; or recovery room and then outputs the measured patient data to a hospital information system (HIS).The Expression Information Portal (Model IP5); a display and device controller for Philips MRI patient monitoring systems; is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures.             Invivo Corporation located at 12151 Research Parkway; Orlando; FL 32826 is recalling the Expression Information Portal (Model IP5). Upon power up; the IP5 may fail to produce audio.

GE Healthcare; LLC          Feb-14-2014       GE Healthcare; PET Discovery 610; Discovery 710; Discovery 600 and Discovery 690. – GE Healthcare; PET Discovery 610; Discovery 710; Discovery 600 and Discovery 690.The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation; diagnosis; staging; restaging; and follow up of lesions; disease and organ function such as (but not limited to) cancer; cardiovascular disease; and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems.  GE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection associated with the List Mode Replay feature of your Discovery 600; 610; 710 and Discovery 690.

Beckman Coulter Inc.     Feb-16-2014       UniCel DxI 600 Access Immunoassay System Analyzer – UniCel DxI 600 Access Immunoassay System Analyzer. K023764.The Access Immunoassay System is an in vitro diagnostic device used for the quantitative; semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.                Beckman Coulter initiated a recall of the Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access becausethey may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results.

Synthes; Inc.      Feb-16-2014       Synthes 3.2 mm Guide Wire 400mm – Synthes 3.2 mm Guide Wire 400mm.Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.            Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.

Beckman Coulter Inc.     Feb-16-2014       Access 2; Immunoassay System Analyzer – Access 2 Immunoassay System Analyzer. K922823/A007.The Access Immunoassay System is an in vitro diagnostic device used for the quantitative; semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.         Beckman Coulter initiated a recall of the Access 2 Beckman Coulter initiated a recall of the Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access becausethey may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results.

Siemens Hearing Instruments; Inc            Feb-18-2014       Siemens Hearing Instruments Inc. – Siemens Prisma 2K Hearing AidProduct Usage:A behind the ear (BTE) hearing aid developed for pediatric patients.  Siemens became aware of an issue where an infant or child could open the tamper resistant battery compartment of the Siemens Prisma 2K hearing aid under certain unintended use conditions.

B. Braun Medical; Inc.    Feb-18-2014       B. Braun SAFSITE Injection Sites and IV Sets – SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites.A device used to administer fluids from a container to a patient’s vascular system through a needle or catheter inserted into a vein.            Complaints were received reporting leakage on certain lots of SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites.The SAFSITE Injection Site is intended to provide needle free access on IV and Extension Sets.

Perrigo Diabetes Care    Feb-19-2014       Orbit soft Infusion sets – Orbit soft Infusion sets; 9 mm soft cannula; P10 (42") tubing; Single-Use SetOrbit Infusion Sets are sterile; non-pyrogenic; single-use devices intended to be used for subcutaneous delivery of medication ; for example insulin; from an external infusion pump.       Perrigo was notified by our supplier; Ypsomed AG; that they are recalling these batches due to being manufactured with a non-conforming female luer-lock connector. The luer-lock connectors are incompatible with standard male luer-lock connectors for use in connection to compatible infusion pumps.  Perrigo became was notified of a quality complaint related to this issue on November 20; 2013 from a

Biocardia; Inc.    Feb-19-2014       Catheter introducer – MORPH ACCESSPRO Steerable Introducer;6F introducer; 90 cm working length:Sterile in unopened; undamaged pouch. Sterilized by EtO gas; Non-pyrogenic:BioCardia Inc.San Carlos; CA 94070Intended to provide a pathway through which medical instruments such as balloon dilation catheters; guidewires and other therapeutic devices may be introduced into the peripheral vasculature.    Tyvek packaging may be worn; causing loss of package integrity.

The Standing Company Feb-19-2014       Superstand stand-up wheelchair – Superstand stand-up wheelchairHPS-2A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.                Power Superstand Standing Wheel chair; flex shaft (the flexible wand which supports the joystick control module) may fracture if it is bent repeatedly and /or beyond 90 degrees. A newly designed Flexshaft which corrects this problem is available at no charge.

Synthes; Inc.      Feb-19-2014       Synthes Matrix Mandible Short Threaded Drill Guide – Synthes Matrix Mandible Short Threaded Drill Guide intended for oral; maxillofacial surgery; trauma and reconstructive surgery; specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible.         One lot of Matrix Mandible Short Threaded Drill Guides (part No. 03.503.043) has a gray colored band instead of a green colored band as pictured in the Technique Guide.

Aesculap; Inc.    Feb-19-2014       Aesculap – Aesculap proSA Adjustment Disc Size Large (L)The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.             The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.

Synthes; Inc.      Feb-20-2014       Synthes – Synthes Driving Cap/ThreadedBoth parts are intended for use in the Tibia system; LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired; the nail can then be inserted using light hammer blows.  The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate.

Medtronic Inc. Cardiac Rhythm Disease Management    Feb-20-2014       Medtronic Select 3D Arterial Cannula – Medtronic Select 3D Arterial Cannulae.  Vented; model 78624  (24 Fr.).  Non-Vented Cannulae; model 78724 (24 Fr.).  Sterilized using Ethylene Oxide.  Non-pyrogenic.  The Cannula consists of a curved; angled or beveled tip with or without flange that is permanently attached to a molded; clear; flexible PVC tapered body or wirebound PVC body.  The cannula body features a tip orientation line to indicate direction of the cannula tip during cannulation.  The proximal end of the cannula includes a connection site or a molded 0.95 cm (3/8 in) barbed connector with or without a molded plastic vent plug or peel cap.  The vent plug or peel cap allows air to be vented from the cannula before connection to the perfusion line.  These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.                Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.

Medtronic Inc. Cardiac Rhythm Disease Management    Feb-20-2014       Medtronic Select CAP Arterial Cannula – Medtronic Select CAP Arterial Cannulae.  Vented; models 78818  (18 Fr.); 78820 (20 Fr.); 78822 (22 Fr.).  Non-Vented Cannulae; model 78920 (20 Fr.); 78922 (22 Fr.); 78924 (24 Fr.).  Sterilized using Ethylene Oxide.  Non-pyrogenic.  The Cannula consists of a curved; angled or beveled tip with or without flange that is permanently attached to a molded; clear; flexible PVC tapered body or wirebound PVC body.  The cannula body features a tip orientation line to indicate direction of the cannula tip during cannulation.  The proximal end of the cannula includes a connection site or a molded 0.95 cm (3/8 in) barbed connector with or without a molded plastic vent plug or peel cap.  The vent plug or peel cap allows air to be vented from the cannula before connection to the perfusion line.  The proximal end features a pressure monitoring line with a 3-way stopcock.These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.             Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.

Medtronic Inc. Cardiac Rhythm Disease Management    Feb-20-2014       Medtronic Select 3D Arterial Cannula – Medtronic Select 3D Arterial Cannulae.  Vented; models 78618  (18 Fr.) and 78620 (20 Fr.).  Non-Vented Cannulae; models 78718 (18 Fr.) and 78720 (20 Fr.).  Sterilized using Ethylene Oxide.  Non-pyrogenic.  The Select 3D Arterial Cannulae both have clear flexible; thin wall wire-wound PVC bodies with angled; beveled tips.  The proximal end of the cannula includes a 3/8" (0.95 cm) vented or non-vented connector with a peel cap.  The vented connector allows air to be vented from the cannula before connection to the perfusion line.  The Select 3D Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow.  The cannula body features a tip orientation line indicating direction of the cannula tip during cannulation.  Overall cannula length is 11.5" (29.2 cm).  These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.            Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.

Bausch & Lomb Surgical; Inc.       Feb-20-2014       AKREOS AO Micro Incision Lens – Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.               Lens was manufactured with incorrect raw material.

Elekta; Inc.          Feb-20-2014       Synergy XVI – Synergy XVIXVI can incorrectly calculate the target position of the treatment table; because of an error that does not occur very frequently. This is the sequence of events when this error occurs – (1) You do an online VolumeView acquisition and registration. (2) You accept the registration and the Table Move Assistant dialog box appears. (3) The Relative Actual column of the Table Move Assistant dialog box incorrectly appears blank. (4) When this occurs; XVI does not read the Absolute Actual position of the treatment table. This causes XVI to calculate the treatment table moves from the zero position of the treatment table (+0.0; + 0.0; + 0.0). (5) In XVI R5.0; if the Relative Set values are less than or equal to + or -2.5cm (for earlier releases of XVI; the value is + or -2cm); you can do remote automatic table movement (RATM) from the function keypad (FKP). (6) When you press the Table ASU (automatic setup) buttons; the treatment table moves to a position that was incorrectly calculated from XVI.             XVI can incorrectly calculate the target position of the treatment table.

Medtronic Inc. Cardiac Rhythm Disease Management    Feb-20-2014       Medtronic Custom Tubing Pack – Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae.  Model 3Y90R3; the following model is only approved in Europe C300901B.  Sterilized using Ethylene Oxide.  Non-pyrogenic.  The design and components of this product are specified by the user.  This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures.        Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.

Medtronic Inc. Cardiac Rhythm Disease Management    Feb-20-2014       Medtronic Select CAP Arterial Cannula Carmeda coated – Medtronic Select CAP Arterial Cannulae.  Non-Vented; Carmeda Coated; model CB78722 (22 Fr.).  Sterilized using Ethylene Oxide.  Non-pyrogenic.  The Select 3D Arterial Cannulae has clear flexible; thin wall wire-wound PVC bodies with angled; beveled tips.  The proximal end of the cannula includes a 3/8" (0.95 cm) vented or non-vented connector with a peel cap.  The vented connector allows air to be vented from the cannula before connection to the perfusion line.  The Select 3D Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow.  The cannula body features a tip orientation line indicating direction of the cannula tip during cannulation.  Overall cannula length is 11.5" (29.2 cm).  These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.             Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.

Medtronic Inc. Cardiac Rhythm Disease Management    Feb-20-2014       Medtronic Select 3D Arterial Cannula – Medtronic Select 3D Arterial Cannulae.  Vented; model 78622  (22 Fr.).  Non-Vented Cannulae; model 78722 (22 Fr.).  Sterilized using Ethylene Oxide.  Non-pyrogenic.  The Cannula consists of a curved; angled or beveled tip with or without flange that is permanently attached to a molded; clear; flexible PVC tapered body or wirebound PVC body.  The cannula body features a tip orientation line to indicate direction of the cannula tip during cannulation.  The proximal end of the cannula includes a connection site or a molded 0.95 cm (3/8 in) barbed connector with or without a molded plastic vent plug or peel cap.  The vent plug or peel cap allows air to be vented from the cannula before connection to the perfusion line. These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.                Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.

Elekta; Inc.          Feb-20-2014       Synergy x-ray volume imaging (XVI); Elekta Synergy; Elekta Synergy S and XVI – Synergy XVIThe Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases; as determined by a licensed medical practitioner.  Potential collision risk when using XVI and external beam shaping devices.

Zimmer; Inc.       Feb-20-2014       VerSys LD/FX Pressfit – PRESSFIT FEM ST FX 16 X 1            Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Herbert/Whipple Bone Screw System and Herbert Mini Bone Screw – HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with 0011500 and 0011520.              Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       ITST Intratrochanteric/subtrochanteric Fixation – ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900.  Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Versys Endo/Unipolar Heads and Standard CoCr Heads – 6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE             Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       M/DN Intramedullary Fixation – RECON SCREW LG 5.5MM DIA  and M/DN FEM IM NAIL 8MM DIA  to 16 MM DIA. Item codes starting with 0022520; 0022521; 002522; 0022523; 0022524 and 0022525.      Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       M/DN Intramedullary Fixation – INTERLOCKING IM SCREW SML; MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM.Some items starting with codes 0022530; 0022531; 002532; 0022533; 0022534  Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Moore Press-Fit; One Piece and Thompson; One Piece – MOORE HIP PROS LONG FENES; MOORE HIP PROS NRW STR FE; MOORE HIP PROS STR FENEST; THOMPSON HIP PROSTHESIS sizes 3; 4; 5; and 6; and Mod Austin Moore Fem Stem              Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       M/DN Intramedullary Fixation – M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541; 002542 and 0022543.            Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Moore Cemented – MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID                Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Herbert Bone Screw – HERBERT BONE SCREW; 3.0MM and HERBERT CANNULATED BONE S                Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       HGP II ACETABULAR CUP MOD – HGP II ACETABULAR CUP MOD                Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       NexGen Complete Knee Solution – NEXGEN OSTEOTOMY CORT BON. Item codes starting with 0052500      Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Zimmer Universal Locking System – 3.5 X 10 CORT SCREW SELFT3.5 X 12 CORT SCREW SELFT3.5 X 14 CORT SCREW SELFT3.5 X 16 CORT SCREW SELFT3.5 X 18 CORT SCREW SELFT3.5 X 20 CORT SCREW SELFT3.5 X 22 CORT SCREW SELFT3.5 X 24 CORT SCREW SELFT3.5 X 26 CORT SCREW SELFT3.5 X 28 CORT SCREW SELFT3.5 X 30 CORT SCREW SELFT3.5 X 32 CORT SCREW SELFT3.5 X 34 CORT SCREW SELFT3.5 X 36 CORT SCREW SELFT3.5 X 38 CORT SCREW SELFT3.5 X 40 CORT SCREW SELFT3.5 X 45 CORT SCREW SELFT3.5 X 50 CORT SCREW SELFT3.5 X 55 CORT SCREW SELFT3.5 X 60 CORT SCREW SELFT3.5 X 75 CORT SCREW SELFT              Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Zimmer Plates and Screws System – 3.5 COMP PLT; 4 HOLE     3.5 COMP PLT; 5 HOLE     3.5 COMP PLT; 6 HOLE     3.5 COMP PLT; 8 HOLE     3.5 COMP PLT; 9 HOLE     3.5 COMP PLT; 10 HOLE    Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       VerSys Heritage – VERSYS HERITAGE FEM STEM Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Versys CoCr Heads – 12/14 COCR FEMORAL HEAD (2; 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M)    Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Versa-Fx II Femoral Fixation System – VERSA-FX II KEYLESS TUBE; VERSA-FX II KEYLESS SHORT; VERSA-FX II SHORT TUBE PL; VERSA-FX II STD TUBE PLAT and VERSA-FX II SUPRACONDYLR Item codes starting with 0011930; 0011931 and 0011941   Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Bipolar liners and multipolar cups – Bipolar liners and Multipolar cups with the following dimensions in MM (38; 39; 40; 41; 42; 43; 44; 45; 46; 47; 48; 49; 50; 53; 54; 55; 57; 58; 60; 64; 66; 68; 70; 72) and several OD                Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Versa-Fx Femoral Fixation System – VERSA-FX KEYLESS 90D X 8 and X 11; VERSA-FX KEYLESS 95D X 8; X 11; and X 14; VERSA-FX KEYLESS 140D X 4 and X 5; VERSA-FX KEYLESS 135D X 4 and X 5; VERSA-FX SHORT TUBE; 130D; 135D and 140D; VERSA-FX STANDARD TUBE; 1 and VERSA-FX SPRCNDLR TUBE; 9Item codes starting with 001980; 001981; 0011990 and 0011991     Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Zimmer Periarticular Plating System – DISTAL MEDIAL FEMORAL CON; DISTAL POSTERIOR/LATERAL; DISTAL SMALL VOLAR RADIUS; PROXIMAL DORSAL ULNA PLT; and PROXIMAL MEDIAL TIBIAL 4.                Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       CPT 12/14 – CPT 12/14 COCR (various sizes)          Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Magna-Fx Cannulated Screw Fixation System – Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420; 11460 and 11461.        Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Zimmer Periarticular Plating System – PERI SCR. 3.5MM X 10MM   PERI SCR. 3.5MM X 12MM   PERI SCR. 3.5MM X 14MM   PERI SCR 3.5MM X 44MM STEPERI SCR. 3.5MM X 65MM   PERI. SCR 4.0MM X24MM    PERI. SCR 4.0MM X40MM    PERI SCR. 4.0MMX14MM FULLPERI SCR. 4.0MMX32MM FULLPERI SCR. 4.0MMX38MM FULL3.5MM CORT SCR X 10MM    3.5MM CORT SCR X 12MM    3.5MM CORT SCR X 14MM    3.5MM CORT SCR X 16MM    3.5MM CORT SCR X 18MM    3.5MM CORT SCR X 20MM    3.5MM CORT SCR X 22MM    3.5MM CORT SCR X 24MM    3.5MM CORT SCR X 26MM    3.5MM CORT SCR X 28MM    3.5MM CORT SCR X 30MM    3.5MM CORT SCR X 32MM    3.5MM CORT SCR X 34MM    3.5MM CORT SCR X 36MM    3.5MM CORT SCR X 38MM    3.5MM CORT SCR X 40MM    3.5MM CORT SCR X 42MM    3.5MM CORT SCR X 44MM    3.5MM CORT SCR X 46MM    3.5MM CORT SCR X 48MM    3.5MM CORT SCR X 50MM    3.5MM CORT SCR X 52MM    3.5MM CORT SCR X 54MM    3.5MM CORT SCR X 56MM    3.5MM CORT SCR X 58MM    3.5MM CORT SCR X 60MM    3.5MM CORT SCR X 65MM    3.5MM CORT SCR X 70MM    3.5MM CORT SCR X 75MM    3.5MM CORT SCR X 80MM    3.5MM CORT SCR X 85MM    3.5MM CORT SCR X 90MM    3.5MM CORT SCR X 100MM   3.5MM CORT SCR X 105MM   3.5MM CORT SCR X 110MM   CANC SCR 4.0MM X 10MM    CANC SCR 4.0MM X 10MM FULCANC SCR 4.0MM X 12MM    CANC SCR 4.0MM X 12MM FULCANC SCR 4.0MM X 14MM    CANC SCR 4.0MM X 14MM FULCANC SCR 4.0MM X 16MM    CANC SCR 4.0MM X 16MM FULCANC SCR 4.0MM X 18MM    CANC SCR 4.0MM X 18MM FULCANC SCR 4.0MM X 20MM    CANC SCR 4.0MM X 20MM FULCANC SCR 4.0MM X 22MM    CANC SCR 4.0MM X 22MM FULCANC SCR 4.0MM X 24MM    CANC SCR 4.0MM X 24MM FULCANC SCR 4.0MM X 26MM    CANC SCR 4.0MM X 26MM FULCANC SCR 4.0MM X 28MM    CANC SCR 4.0MM X 28MM FULCANC SCR 4.0MM X 30MM    CANC SCR 4.0MM X 30MM FULCANC SCR 4.0MM X 32MM    CANC SCR 4.0MM X 32MM FULCANC SCR 4.0MM X 34MM    CANC SCR 4.0MM X 34MM FULCANC SCR 4.0MM X 36MM    CANC SCR 4.0MM X 36MM FULCANC SCR 4.0MM X 38MM    CANC SCR 4.0MM X 38MM FULCANC SCR 4.0MM X 40MM    CANC SCR 4.0MM X 40MM FUL          Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Standard CoCr Heads – 6 DEGREE COCR FEM HEAD 36      Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       M/DN Intramedullary Fixation – M/DN R-F IM NAIL 9MM DIA ; 10 MM; 11 MM; 12 MM; 13 MM and 14 MM. Item codes starting with 0022400           Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       FREE-LOCK FEMORAL HIP FIXATION SYSTEM – FREE-LOCK LAG SCREW; 12.7; FREE-LOCK LAG SCREW; 15.8; FREE-LOCK SUPRACOND TUBE and FREE-LOCK TUBE & SCP PLAT. Items starting with codes 0011810 and 0011811.              Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       M/DN Intramedullary Fixation – INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LGSome items starting with codes 0022530           Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Versys ION CoCr Heads – FEM HD ION   (various sizes)     Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       CPT Stainless Long Stems; Standard ION CoCr Heads and Other cemented  hips – CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)  Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Trilogy Conventional Polyethylene Liners – MODULAR CUP NEUTRAL LINERMODULAR CUP 10 DEGREE LINMODULAR CUP 20 DEGREE LINMODULAR CUP 7MM OFFSET LI     Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       ITST Intratrochanteric/subtrochanteric Fixation – ITST ANTI-ROTATION SCREW  and FEM IM NAIL (10MM; 11 MM; 12 MM; 13 MM; 14 MM and 15 MM) DIA X  (18; 30; 32; 34; 36; 38; 40; 42; 44; 46; 48 and 50)                Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Zimmer Universal Locking System – 2.7 X 6 CORT SCREW/SELFTA2.7 X 7 CORT SCREW/SELFTA2.7 X 8 CORT SCREW/SELFTA2.7 X 9 CORT SCREW/SELFTA2.7 X 10 CORT SCREW/SELFT2.7 X 12 CORT SCREW/SELFT2.7 X 14 CORT SCREW/SELFT2.7 X 16 CORT SCREW/SELFT2.7 X 18 CORT SCREW/SELFT2.7 X 20 CORT SCREW/SELFT2.7 X 22 CORT SCREW/SELFT2.7 X 24 CORT SCREW/SELFT2.7 X 26 CORT SCREW/SELFT2.7 X 28 CORT SCREW/SELFT2.7 X 30 CORT SCREW/SELFT2.7 X 32 CORT SCREW/SELFT2.7 X 34 CORT SCREW/SELFT2.7 X 36 CORT SCREW/SELFT2.7 X 38 CORT SCREW/SELFT2.7 X 40 CORT SCREW/SELFT2.7 X 42 CORT SCREW/SELFT2.7 X 44 CORT SCREW/SELFT2.7 X 45 CORT SCREW/SELFT2.7 X 46 CORT SCREW/SELFT2.7 X 48 CORT SCREW/SELFT2.7 X 50 CORT SCREW/SELFT4.0 X 20 CANC SCREW/SELFT            Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Versys – 12/14 UNIPOLAR FEMORAL HEVERSYS CEM LD/FX SZ 11X12VERSYS CEM LD/FX SZ 12X12VERSYS CEM LD/FX SZ 14X13VERSYS CEM LD/FX SZ 16X14VERSYS CEM LD/FX ST 18X15VERSYS PRESS FIT LD/FX STVERSYS PRESS FIT LD/FX SZVERSYS ADVOCATE CEMENTED VERSYS ADVOCATE V-LIGN CEVERSYS CEMENTED FEM STEM VERSYS CT FEM STEM 11X120VERSYS CT FEM STEM 12X125VERSYS CT FEM STEM 13X130VERSYS CT FEM STEM 14X135VERSYS CT FEM STEM 15X140VERSYS CT FEM STEM 16X145VERSYS CT FEM STEM 17X150VERSYS CEM/REV/CALCAR 13XVERSYS CEM/REV/CALCAR 15XVERSYS CEM/REV/CALCAR 17XVERSYS CEM/REV/CALCAR 19X                Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       NexGen Complete Knee Solution – NEXGEN MIS TIBIA PLATE PRNEXGEN TAPER PLUG        NEXGEN PRECOAT PEG TIB PLNEXGEN MICRO ALL-POLY PATNEXGEN ALL-POLY PATELLA; NEXGEN PRECOAT STEMMED TINEXGEN OPTION STEMMED TIBNEXGEN STRAIGHT STEM EXT NEXGEN SHARP FLUTED STEM NEXGEN FLUTED STEM EXT; 1NEXGEN FLUTED STEM EXT; 2NEXGEN CEMENTED STEM EXT     Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Versa-Fx Femoral Fixation System – Item codes starting with 001930LAG SCR 12.7D X 55MM SHOR up to 155 MM; LAG SCR 12.7D X 55 MM SHO up to 100MM;  LAG SCR 12.7D X 55MM STAN up to 155 MM; LAG SCR 15.8D X 55MM LARG up to 155 MM         Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       ITST Intratrochanteric/subtrochanteric Fixation – ASIA ONE-PIECE LAG SCREW    Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Versa-Fx II Femoral Fixation System – COMPRESSION SCREW (1/2; 1-1/2; 1-1/4; 1-3/4; 1. 2. 3/4 IN)  Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Zimtron/Stainless Steel Heads – ZIMTRON 6 DEG 22 HEADS           Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       HGPII Screws – HGP II ACETABULAR CUP BON     Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Zimmer Plates and Screws System/Zimmer Universal Locking System – 1.5 X 6 CORT SCREW HEX/SE2.0 X 6 CORT SCREW HEX/SE2.0 X 10 CORT SCREW CRUCI2.0 X 12 CORT SCREW CRUCI2.0 X 14 CORT SCREW CRUCI2.0 X 16 CORT SCREW HEX/S2.0 X 16 CORT SCREW CRUCI2.0 X 18 CORT SCREW CRUCI2.0 X 20 CORT SCREW CRUCI2.0 X 26 CORT SCREW CRUCI2.0 X 28 CORT SCREW CRUCI2.0 X 30 CORT SCREW CRUCI2.0 X 32 CORT SCREW CRUCI2.0 X 34 CORT SCREW CRUCI2.0 X 36 CORT SCREW CRUCI2.0 X 38 CORT SCREW CRUCI2.0 X 40 CORT SCREW CRUCI2.0 X 42 CORT SCREW CRUCI2.0 X 44 CORT SCREW CRUCI2.0 X 46 CORT SCREW CRUCI2.0 X 48 CORT SCREW CRUCI2.0 X 50 CORT SCREW CRUCI2.7MM CORT. SCREW 6MM; ST2.7MM CORT. SCREW 7MM; ST2.7MM CORT. SCREW 8MM; ST2.7MM CORT. SCREW 9MM; ST2.7MM CORT. SCREW 10MM; S2.7MM CORT. SCREW 12MM; S2.7MM CORT. SCREW 14MM; S2.7MM CORT. SCREW 16MM; S2.7MM CORT. SCREW 18MM; S2.7MM CORT. SCREW 20MM; S2.7MM CORT. SCREW 22MM; S2.7MM CORT. SCREW 24MM; S2.7MM CORT. SCREW 26MM; S2.7MM CORT. SCREW 28MM; S2.7MM CORT. SCREW 30MM; S2.7MM CORT. SCREW 32MM; S2.7MM CORT. SCREW 34MM; S2.7MM CORT. SCREW 36MM; S2.7MM CORT. SCREW 38MM; S2.7MM CORT. SCREW 40MM; S2.7MM CORT. SCREW 42MM; S2.7MM CORT. SCREW 44MM; S2.7MM CORT. SCREW 45MM; S2.7MM CORT. SCREW 46MM; S2.7MM CORT. SCREW 48MM; S2.7MM CORT. SCREW 50MM; S2.7X52 CORT SCREW/SELFTAP2.7X54 CORT SCREW/SELFTAP2.7X55 CORT SCREW/SELFTAP2.7X56 CORT SCREW/SELFTAP2.7X58 CORT SCREW/SELFTAP2.7X60 CORT SCREW/SELFTAP2.7X65 CORT SCREW/SELFTAP2.7X70 CORT SCREW/SELFTAP3.5MM CORT. SCREW 10MM LN3.5MM CORT. SCREW 12MM LN3.5X14 CORT SCREW        3.5MM CORT. SCREW 14MM LN3.5X16 CORT SCREW        3.5MM CORT. SCREW 16MM LN3.5 X 16 SHAFT SCREW     3.5X18 CORT SCREW        3.5MM CORT. SCREW 18MM LN3.5 X 18 SHAFT SCREW     3.5MM CORT. SCREW 20MM LN3.5 X 20 SHAFT SCREW     3.5MM CORT. SCREW 22MM LN3.5 X 22 SHAFT SCREW     3.5MM CORT. SCREW 24MM LN3.5 X 24 SHAFT SCREW     3.5MM CORT. SCREW 26MM LN3.5 X 26 SHAFT SCREW     3.5MM CORT. SCREW 28MM LN3.5 X 28 SHAFT SCREW     3.5MM CORT. SCREW 30MM LN3.5 X 30 SHAFT SCREW     3.5MM CORT. SCREW 32MM LN3.5 X 32 SHAFT SCREW     3.5MM CORT. SCREW 34MM LN3.5 X 34 SHAFT SCREW     3.5MM CORT. SCREW 36MM LN3.5 X 36 SHAFT SCREW     3.5MM CORT. SCREW 38MM LN3.5 X 38 SHAFT SCREW     3.5MM CORT. SCREW 40MM LN3.5 X 40 SHAFT SCREW     3.5MM CORT. SCREW 45MM LN3.5MM CORT. SCREW 50MM LN3.5 X 50 SHAFT SCREW     3.5MM CORT. SCREW 55MM LN3.5MM CORT. SCREW 60MM LN3.5MM CORT. SCREW 65MM LN3.5MM CORT. SCREW 70MM LN3.5MM CORT. SCREW 75MM LN3.5MM CORT. SCREW 80MM LN3.5X85 CORT SCREW        3.5X90 CORT SCREW        3.5X95 CORT SCREW        3.5X100 CORT SCREW       3.5X105 CORT SCREW       3.5X110 CORT SCREW       3.5X115 CORT SCREW       3.5X120 CORT SCREW       3.5X125 CORT SCREW       3.5X130 CORT SCREW       3.5X135 CORT SCREW       3.5X140 CORT SCREW       3.5X145 CORT SCREW       3.5X150 CORT SCREW       4.0 X 10 CANCELL. SCREW  4.0 X 10 PART THD CANC SC4.0 X 12 CANCELL. SCREW  4.0 X 12 PART THD CANC SC4.0 X 14 CANCELL. SCREW  4.0 X 14 PART THD CANC SC4.0 X 16 CANCELL. SCREW  4.0 X 16 PART THD CANC SC4.0 X 18 CANCELL. SCREW  4.0 X 18 PART THD CANC SC4.0 X 20 CANCELL. SCREW  4.0 X 20 PART THD CANC SC4.0 X 22 CANCELL. SCREW  4.0 X 22 PART THD CANC SC4.0 X 24 CANCELL. SCREW  4.0 X 24 PART THD CANC SC4.0 X 26 CANCELL. SCREW  4.0 X 26 PART THD CANC SC4.0 X 28 CANCELL. SCREW  4.0 X 28 PART THD CANC SC4.0 X 30 CANCELL. SCREW  4.0 X 30 PART THD CANC SC4.0 X 32 CANCELL. SCREW  4.0 X 34 CANCELL. SCREW  4.0 X 35 PART THD CANC SC4.0 X 36 CANCELL. SCREW  4.0 X 40 CANCELL. SCREW  4.0 X 40 PART THD CANC SC4.0 X 45 CANCELL. SCREW  4.0 X 45 PART THD CANC SC4.0 X 50 CANCELL. SCREW  4.0 X 50 PART THD CANC SC4.0 X 55 CANCELL. SCREW  4.0 X 55 PART THD CANC SC4.0 X 60 CANCELL. SCREW  4.0 X 60 PART THD CANC SC4.0 X 65 CANCELL. SCREW  4.0     Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Insall/Burstein and MG II Total Knee System – I/B II KNEE DOMED PATELLA; I/B II KNEE FLUTED ROD (1 and 2); MGII KNEE 10MM PATELLA (2;3 and 4); MGII KNEE SLF-TAP BONE ST         Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Trilogy cups and screws – TRILOGY ACET SHELL 36MM OTRILOGY ACET SHELL 38MM OTRILOGY ACET SHELL 40MM OTRILOGY ACET SHELL 42MM OTRILOGY ACET SHELL 44MM OTRILOGY ACET SHELL 46MM OTRILOGY ACET SHELL 48MM OTRILOGY ACET SHELL 50MM OTRILOGY ACET SHELL 52MM OTRILOGY ACET SHELL 54MM OTRILOGY ACET SHELL 56MM OTRILOGY ACET SHELL 58MM OTRILOGY ACET SHELL 60MM OTRILOGY ACET SHELL 62MM OTRILOGY ACET SHELL 64MM OTRILOGY ACET SHELL 66MM OTRILOGY ACET SHELL 68MM OTRILOGY ACET SHELL 70MM OTRILOGY ACET SHELL 72MM OTRILOGY ACET SHELL 74MM OTRILOGY ACET SHELL 76MM OTRILOGY ACET SHELL 78MM OTRILOGY ACET SHELL 80MM OBONE SCREW 4.5X15 SELF-TABONE SCREW 4.5X20 SELF-TABONE SCREW 4.5X25 SELF-TABONE SCREW 4.5X30 SELF-TABONE SCREW 4.5X35 SELF-TABONE SCREW 4.5X40 SELF-TABONE SCREW 4.5X50 SELF-TABONE SCREW 4.5X60 SELF-TABONE SCREW 6.5X15 SELF-TABONE SCREW 6.5X20 SELF-TABONE SCREW 6.5X25 SELF-TABONE SCREW 6.5X30 SELF-TABONE SCREW 6.5X35 SELF-TABONE SCREW 6.5X40 SELF-TABONE SCREW 6.5X50 SELF-TABONE SCREW 6.5X60 SELF-TABONE SCREW 6.5X70 SELF-TABONE SCREW 6.5X80 SELF-TA            Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Mod Moore Pressfit – MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001; 455503001 and 455504001            Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Zimmer; Inc.       Feb-20-2014       Thompson; One Piece and Moore Press-Fit; One Piece – MOORE HIP PROS LONG FENES; MOORE HIP PROS NRW STR FE; MOORE HIP PROS STR FENEST; THOMPSON HIP PROSTHESIS 3; 4; 5 and 6.             Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce; Puerto Rico. Based on this review; it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result; Zimmer conducted seal integrity testing to evaluate if previously packaged pro

Integra LifeSciences Corp.            Feb-20-2014       Integra LifeSciences Corporation – Integra Cusa Excel Rx OnlyCEM" Noseconefor CUSA Excel SystemProduct Usage:Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System; CUSA handpiece; and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired; either simultaneously or independently.    The blue COAG button on the CUSA Excel CEM nosecone could stick in the ‘activated’ position.

Biosense Webster; Inc. Feb-20-2014       CARTOUNIVU MODULE – CartoUnivu Module; Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124WITH THE CARTOUNIVU MODULE; FLUOROSCOPIC CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAYED IN THE CART0 3 SYSTEM. THESE IMAGES ARE NOT FOR DIAGNOSTIC PURPOSES. WHEN FLUOROSCOPIC CAPTURES ARE INTEGRATED INTO THE CART0 3 SYSTEM MAP VIEWERS (MAP VIEWER AND ADDITIONAL VIEW); CART0 3 MAPS; MRl OR CT IMAGES; AND CATHETER VISUALIZATION ARE SUPERIMPOSED ON THE FLUOROSCOPIC CAPTURE.           Biosense Webster has initiated a recall of the  CartoUnivu Module within the Carto 3 System (V3.2.2 and V3.2.3) when used with Siemens Axiom Artis VB Fluoroscopy systems in particular procedural configurations only.  If the table rotation is not returned to zero point; there is a misalignment between the Carto 3 System map display and the fluoroscopic capture.

BioHorizons Implant Systems Inc              Feb-20-2014       External Implant RBT; D3 Threadform 4.0 X 10.5mm; REF  40105D3 – External Implant RBT; D3 Threadform 4.0 X 10.5mm; REF  40105D3; STERILE R; Rx Only; BioHorizons(R); 2300 Riverchase Center; Birmingham; AL  35244Usage: dental      The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.

Implantech Associates Inc            Feb-20-2014       Gelzone Shoulder Sleeve – Gelzone Shoulder Sleeve; Catalog Number SLV634; Lot Number 852766.Product Usage:  To be used where limb support and/or elevation is considered necessary.                Implantech initiated the voluntary recall of Gelzone Shoulder Sleever; SLV-634; Lot Number 852766 because it may not satisfy customer requirements for the robustness of the Velcro closure.

Smith & Nephew Inc      Feb-21-2014       Reflection(R) Interfit(TM) Shell; 52 MM OD; 3 HOLE – Reflection(R) Interfit(TM) Shell; 52 MM OD; 3 HOLE; REF 71336052; QTY 1; STERILE R; Smith & Nephew; Inc.; Memphis; TN 38116 Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post traumatic arthritis; avascular necrosis; femoral and neck fractures; osteomyelitis; fracture; dislocation of the hip; and unsuccessful cup arthroplasty; endoprosthesis; femoral osteotomy; or girdlestone resection.        Inner spherical radius of the shell is undersized.

Terumo Cardiovascular Systems Corporation      Feb-21-2014       Electrosurgical Cutting and Coagulation Device – VirtuoSaph Plus Endoscopic Vessel Harvesting System; Part number: VSP550; Sterile***Rx Only***Product Usage:The VirtuoSaph  Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting; and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass.      Sterility of medical devices intended for use in surgical procedures may be compromised.

Smith & Nephew Inc.     Feb-21-2014       Renasys EZ PLUS – "Renasys EZ PLUS"  a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System         Smith & Nephew has decided to conduct a medical device correction of the RENASYS EZ/EZ Plus Canisters; which are components of the RENASYS EZ and RENASYS EZ Plus Negative Pressure Wound Therapy systems; communicating the modification of the bacterial overflow guard (filter) and related changes to product labeling.

Smith & Nephew Inc.     Feb-21-2014       Renasys EZ – "Renasys EZ"  a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System            Smith & Nephew has decided to conduct a medical device correction of the RENASYS EZ/EZ Plus Canisters; which are components of the RENASYS EZ and RENASYS EZ Plus Negative Pressure Wound Therapy systems; communicating the modification of the bacterial overflow guard (filter) and related changes to product labeling.

Siemens Medical Solutions USA; Inc        Feb-24-2014       Siemens Artis zee Ceiling Systems – Siemens Artis zee Ceiling Systems.Angiographic x-ray system.       During the lifetime of Artis zee Ceiling systems serial numbers from 146352 to 147617; there is an increased wear due to potential sub-optimal cable guidance that can lead to cable damage.

Zimmer; Inc.       Feb-24-2014       Trabecular Metal" Reverse Shoulder System – Trabecular Metal" Reverse Shoulder System                As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate; Zimmer updated the related surgical technique and released a video to provide additional instructions to users on how to properly assemble the Glenosphere to the Baseplate.

Philips Medical Systems (Cleveland) Inc Feb-24-2014       BrightView XCT; BrightView X & BrightView SPECT – Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT; BrightView X & BrightView SPECT) Philips Healthcare Systems; Cleveland; OH.Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. "Three problems were reported to the firm:When positioning for a relative 180 degree non circular acquisition the second (bottom) detector was not positioned correctly causing an inappropriate rotation orbit calculation.  When the acquisition was started and the detectors began to move into position; the incorrect calculation resulted in the detectors coming in contact with the patient.  As"

Radiometer America Inc               Feb-24-2014       ABL700 FKEX and ABL800 FLEX pCO2 membranes – pCO2 D788 Membranes. Distributed by Radiometer America; Inc.; Westlake; OH.An automatic or semi-automatic instrument used to identify and quantify two or more gases; and sometimes electrolytes; in whole blood using multiple special electrodes.                RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results.

Siemens Healthcare Diagnostics; Inc.      Feb-24-2014       Dimension Vista (R) Enzyme 1 Calibrator (ENZ 1 CAL) – Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012.An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY); Gamma-Glutamyl Transferase (GGT); Lactate Dehydrogenase (LDH); Lipase (LIPL); and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.               Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and imprecision during PCHE calibration with the Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012.

NxStage Medical; Inc.    Feb-24-2014       NxStage PureFlow-B Solution – NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401.  Product is packaged in a case containing two individual 5L bags.  The NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.                Mislabeled product.

GE Healthcare; LLC          Feb-24-2014       GE Healthcare Precision 500D – GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1).The Wireless DR Imaging Option ( WDR1); when used with a radiographic imaging system; is indicted for use in general radiographic images of human anatomy. It is intended for use in all routine radiography exams; and specialized areas including pediatric work; intensive care and trauma; wherever conventional screen-film systems or CR systems may be used. The device is not intended for mammography or fluoroscopy applications.              GE Healthcare has recently become aware of a software issue associated with patient selection from the worklist on your WDR1(Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option) that may impact patient safety.Intermittently when a large number of patient exams are retrieved from the HIS/RIS system; the exams when displayed on the WDR1 are not properly displayed. I

DePuy Orthopaedics; Inc.             Feb-24-2014       PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices – PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT)Used during primary total knee arthroplasty to improve patient mobility.             PFC SIGMA Cruciate Retaining (CR) Cemented Femoral devices; product 960015; lots 7810268 and 7806929; were found to have anomalous microstructure. Due to the manufacturing method employed; there may be the potential for increased levels of porosity; as well as blocky grain boundary carbides in the microstructure when compared to parts manufactured under the current accepted and validated protoc

Elekta; Inc.          Feb-25-2014       Model DMLC IV-Ergo; Dynamic Multileaf Collimator – DMLC IV-ERGOProduct Usage:Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible.              It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems

Ortho-Clinical Diagnostics             Feb-25-2014       VITROS Na+ Slides – VITROS Chemistry Products Na+ Slides; manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester; NY 14652VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum; plasma; and urine using VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.               Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results.

Ortho-Clinical Diagnostics             Feb-25-2014       VITROS Chemistry Products Calibrator Kit 2 – VITROS Chemistry Products Calibrator Kit 2; manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester; NY 14606VITROS Chemistry Products Calibrator Kit 2 is used to calibrate VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of CHOL; Cl-; ECO2; K+; Na+; and TRIG.            Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results.

Stryker Spine     Feb-25-2014       Straight Static Inserter Assembly MFG -Part of the AVS navigator Peek Spacer System – Specialty Straight Static Inserter Assembly Product Usage:  This instrument is a part of the Navigator product brand . It is used for implant insertion in to the disc space. The AVS navigator Peek Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal fixation. These hollow implants are offered in a variety of lengths; heights and lordotic angles designed to adapt to different patient anatomies. They have serrations on the superior and inferior surfaces designed for multidirectional fixation and ergonomically shaped anterior edges and flat posterior edges.                Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.

Orthofix; Inc       Feb-25-2014       Azure – Azure Anterior Cervical Plate System; 2-Level Plate; 36 mm; Implant Grade Titanium and Nitinol; Orthofix Inc.; 3451 Plano Pkwy; Lewisville; TX 75056 USA. Tel: 1-888-298-5700/1-214-937-2000; RX OnlyThe Azure Anterior Cervical Plate System is a temporary implant; intended for anterior fixation to the cervical spine from C2 to C7 and is indicated for: A. Degenerative disc disease; B. Spondylolisthesis; C. Trauma; D. Spinal Stenosis; E. Deformities; F. Tumor; G. Pseudoarthrosis; and H. Revision of previous surgery. The Azure Anterior Cervical Plate System is comprised of a variety of non-sterile; single use; titanium alloy and nitinol components. The system is attached to the anterior aspect of the vertebral body by means of screw to to the cervical spine.   There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation.

Instrumentarium Dental; PaloDEx Group Oy        Feb-25-2014       FOCUS – The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator; which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC; which reads the image data from a sensor and displays the image on the PC monitor. In order to make installation and service faster and easier the electronics is integrated into the horizontal arm.FOCUS is intended to be used for producing diagnostic x-ray radiographs of dentition; jaws and other oral structures.             Instrumentarium Dental has delivered a number of FOCUS 3.0 Intraoral X-ray units in November 2013 with a potential flaw in the mounting hardware. A number of wall mount units were delivered with FOCUS X-ray machines that had not been properly welded at our supplier. As a result of the incomplete welding operation; the wall mount unit on the FOCUS X-ray unit may not properly support the unit as exp

Philips Medical Systems; Inc.      Feb-25-2014       HeartStart MRx Monitor/Defribillator – HeartStart MRx Monitor/Defibrillator;  Model(s); Catalogue; or Code Number: M3535A; M3536A; M3536J; M3536MCThe HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support; advanced cardiac support; or defibrillation. It must be used by or on the order of a physician. A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge (ESD); which can disrupt ECG and SpO2 functionality leading to an inability to perform.

Invivo Corporation          Feb-26-2014       Invivo Corporation  Expression IP5 Information Portal – Invivo Corporation  Expression IP5 Information Portal Product Usage:The Expression Information Portal (Model IP5) a display and device controller for Philips MRI patient monitoring systems; is intended for use by trained health care professional to remotely monitor the vital signs of patients undergoing MRI procedures. Available monitoring from the IP5 can include ECG; SpO2; non-invasive and invasive blood pressure; CO2; respiration; anesthetic agents; gases; and temperature parameters.                Invivo Corporation located at 12151 Research Parkway; Orlando; FL 32826 is recalling their Expression Information Portal (Model IP5).  Three different IP5 devices lost audio during use.

Remel Inc            Feb-26-2014       Oxoid Legionella BCYE Growth Supplement. – Oxoid Legionella BCYE Growth Supplement; For 500 ml of medium; SR0110C; packaged 10 vials/box; lyophilized.  The firm name on the label is Oxoid Ltd.; Basingstoke; Hants; England. The product is used for the isolation of Legionella species from clinical and environmental samples. When the product is added to CYE Agar base; it stabilizes pH and provides essential growth factors for the isolation of the Legionella spp.  The product may contain high levels of microbial contamination

Dako North America Inc.               Feb-26-2014       Dako HER2 CISH pharmDx(tm) kit – Product Name: HER2 CISH pharmDx" KitCatalog/Model number: SK109; lot 20000910Product Usage:  For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed; paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Dako Autostainer instruments. HER2 CISH pharmDx Kit is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. Results from the HER2 CISH pharmDx Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II; node-positive breast cancer patients.                Dako has initiated a recall of HER2 CISHpharmDxTM Kit; Code SK109; Lot 20000910; because weak red signals have been observed.

Philips Medical Systems; Inc.      Feb-26-2014       Philips Healthcare – HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion BatteriesRevision JThe HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support; advanced cardiac support; or defibrillation. It must be used by or on the order of a physician                Philips HeartStart MRx Monitor/Defibrillator; when operating on battery power only; may experience an unexpected shutdown if exposed to elevated levels of electromagnetic interference from RF energy source

Philips Medical Systems; Inc.      Feb-26-2014       Philips HeartStart MRx Monitor/Defribillator – Philips HeartStart MRx Monitor/Defibrillator; Models:M3535A; M3536A; M3536J; M3536M; M3536M5; and M3536MC.Used for the termination of ventricular tachycardia and ventricular fibrillation.            ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear; which could result in an interrupted ECG signal

Winco Mfg.; LLC                Feb-26-2014       CONVALESCENT RECLINER – CONVALESCENT RECLINER 5251/5261; 525S/526S with Side Storage Pocket; Upholstered side-panels; Recessed hand-grips; Webbed suspension seating; Non-porous tray.The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation; reclining; eating; patient transport within the facility; and as a patient room chair for visitors.                A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.

Winco Mfg.; LLC                Feb-26-2014       DROP-ARM CONVALESCENT RECLINER – DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms; Built-in headrest; Padded push-handle; Three-position lock; Over-lap tray.The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation; reclining; eating; patient transport within the facility; and as a patient room chair for visitors.  A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.

Philips Medical Systems; Inc.      Feb-26-2014       Philips HeartStart MRx Monitor/Defibrillator – Philips HeartStart MRx Monitor/Defibrillator used Model numbers:  M3535A; M3536A; M3536J; M3536M; M3536MC     HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing risk for patients and/or caregivers

Winco Mfg.; LLC                Feb-26-2014       XL CONVALESCENT RECLINER – XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard; Dual fold down side-tables; Removable side panels; Built-in head-rest.The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation; reclining; eating; patient transport within the facility; and as a patient room chair for visitors.                A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.

Winco Mfg.; LLC                Feb-26-2014       PREMIER CARE RECLINER 5570 – PREMIER CARE RECLINER 5570 with Urethane armrests; Multiple side-table options; 3 position lock-bar; Fully upholstered; OPTIONAL Heat or Heat & Massage; OPTIONAL LiquiCell.The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation; reclining; eating; patient transport within the facility; and as a patient room chair for visitors.  A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.

Fresenius Medical Care Holdings; Inc.     Feb-26-2014       Fresenius Optiflux F160NRe High Flux Dialyzers – Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E.Single Use acute or chronic hemanalysis treatment.        Dialysate Port Leak During Priming of the Dialyzers

Fresenius Medical Care Holdings; Inc.     Feb-26-2014       Fresenius Optiflux F200NR High Flux Dialyzers – Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N.Single Use acute or chronic hemanalysis treatment.       Dialysate Port Leak During Priming of the Dialyzers

Fresenius Medical Care Holdings; Inc.     Feb-26-2014       Fresenius Optiflux F160NR High Flux Dialyzers – Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N.Single Use acute or chronic hemanalysis treatment.       Dialysate Port Leak During Priming of the Dialyzers

Fresenius Medical Care Holdings; Inc.     Feb-26-2014       Fresenius Optiflux B200 Flux Dialyzers – Optiflux B200 Flux Dialyzers; Product Number: 0500325E.Single Use acute or chronic hemanalysis treatment.                Dialysate Port Leak During Priming of the Dialyzers

Fresenius Medical Care Holdings; Inc.     Feb-26-2014       Fresenius Optiflux F180NRe High Flux Dialyzers – Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E.Single Use acute or chronic hemanalysis treatment.        Dialysate Port Leak During Priming of the Dialyzers

Fresenius Medical Care Holdings; Inc.     Feb-26-2014       FreseniusOptiflux F18Nre Flux Dialyzers – Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E.Single Use acute or chronic hemanalysis treatment.            Dialysate Port Leak During Priming of the Dialyzers

Fresenius Medical Care Holdings; Inc.     Feb-26-2014       Fresenius Optiflux F200A High Flux Dialyzers – Optiflux F200A High Flux Dialyzers; Product Number: 0500320A.Single Use acute or chronic hemanalysis treatment.  Dialysate Port Leak During Priming of the Dialyzers

Fresenius Medical Care Holdings; Inc.     Feb-26-2014       Fresenius Optiflux F180NR High Flux Dialyzers – Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N.Single Use acute or chronic hemanalysis treatment.       Dialysate Port Leak During Priming of the Dialyzers

Fresenius Medical Care Holdings; Inc.     Feb-26-2014       Fresenius Optiflux F200NRe High Flux Dialyzers – Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E.Single Use acute or chronic hemanalysis treatment.        Dialysate Port Leak During Priming of the Dialyzers

Hologic; Inc         Feb-26-2014       NovaSure Radiofrequency Control Units – NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller; Model Number: 71978-001Catalog Number: RFC2009Product Usage:  The NovaSure Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in premenopausal women with mehorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.                NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard; IEC 60601-1;

Zimmer; Inc.       Feb-26-2014       Zimmer Trabecular Metal – 00434811113;  REF I4348-111-13Zimmer Trabecular Metal  ShoulderHumeral Stem 48 Degrees11 mm Stem Diameter 130 mm Stem LengthTrabecular Metal" Humeral Stem 48 Degree 11mm x 130mm;   Sterile; QTY 1; RxProduct Usage:  Zimmer Trabecular Metal TM Humeral Stem is a shoulder prosthetic replacement device that is indicated for the treatment of severe pain or significant disability in degenerative; rheumatoid; or traumatic disease of the glenohumeral joint as well as humeral fractures. The humeral stem uses. Trabecular Metal around the proximal part of the stem for biological ingrowth.     This single manufacturing lot has the potential for the bond strength between the Trabecular Metal material and substrate to be below the minimum required specification.  Testing found bond strength approximately 80% of the minimum required by specification in one of the three zones of the Trabecular Metal.  The other two zones exceeded the minimum specification.

Philips Medical Systems; Inc.      Feb-26-2014       HeartStart MRx Monitor/Defribillator – M3536A HeartStart MRx with Wireless Link Upgrade (861289)The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support; advanced cardiac support; or defibrillation. It must be used by or on the order of a physician.                Wireless Link may be unable to transmit data when configured for a specific data flow.

Philips Medical Systems; Inc.      Feb-26-2014       Philips Healthcare – Philips HeartStart XL+ Defibrillator/MonitorModel: 861290The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support; advanced life support or defibrillation. When operating as a semi-automatic external defibrillator in AED Mode; the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes the use of an AED. When operating in Monitor; Manual Defibrillation or Pacing modes; the HeartStart XL+ is suitable for use by healthcare professionals trained in advance life support.            HeartStart XL+ battery charge time to 100% capacity at 35C (95F) is slightly longer than the specified 3 hour duration as stated in the labeling

Ossur Americas; Inc.       Feb-26-2014       The SYMBIONIC LEG – The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Usage:  SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less than 100kg for foot categories 22; 23 and 24. The system is not intended for athletic use.            OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down.

Roche Molecular Systems; Inc.  Feb-26-2014       Roche Molecular Diagnostics Inc. – cobas PCR Urine Kit 100 PKT IVDcobas PCR Female Swab Kit 100 PKT IVDcobas PCR media 100T IVDcobas PCR Female Swab Kit 100 PKT JPN-IVDRoche Molecular Systems; Inc. Branchburg; NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis; IN 46250-0457The cobas PCR media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens and is contained in the cobas PCR Female Swab Kit; cobas PCR Urine kit; and cobas PCR media 100 T kit. -The cobas PCR Urine Sample Kit is used to collect and transport urine specimens. Use this collection kit only with the cobas CT/NG Test. – The cobas PCR Female Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. Use this collection kit only with the cobas CT/NG Test NOTE: This collection kit should not be used for collection of female urine specimens. o For endocervical swab specimens; collections are to be performed by a clinician. o For vaginal swab specimens; collections are to be performed by a clinician or by the patient (self-collection) -In US labeling; it indicates Self collection in a clinical setting. – In ex-US labeling; it indicates Clinician Instructed Self- Collection and Ensure the patient has read and understood the following self-collection instructions before providing a collection kit. – In some countries (e.g.; UK); the sample collection kit is provided as self-collection for home / personal use; which may not be used in a controlled clinical setting and it is unknown if any instructions are provided. – The cobas PCR media kit is used to stabilize and transport urine specimens. Use this kit only with the cobas CT/NG Test. Numerous complaints have been filed that leaking cobas  PCR media 4.3 mL IVD have been received from different lots of thecobas  PCR Urine kits; cobas  PCR Female Swab kits; and cobas  PCR media kits.

Philips Medical Systems; Inc.      Feb-26-2014       Philips Hearstart XL – Philips HeartStart XL; Defibrillator/MonitorModel number M4735AProduct Usage:  The M4735A HeartStart XL Defibrillator/Monitor is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support; advanced cardiac life support; or defibrillation. It must be used by or on the order of a physician. When operating as a semi-automatic external defibrillator in AED Mode; the M4735A HeartStart XL Defibrillator/Monitor is suitable for use by medical personnel trained in basic life support that includes the use of an AED         Philips HeartStart XL may experience a power board failure causing failure to defibrillate