In another blow to the metal-on-metal hip implant market, orthopedic giant Zimmer Holdings (NYSE:ZMH) canceled its Durom Acetabular Component from the Australian Register of Therapeutic Goods, the regulatory agency announced this week.
Recalls
Recall: Hospira infusion pump touchscreen issue gets Class I status from FDA
J&J surgical stapler recall gets Class I status from the FDA | MassDevice.com On Call
MASSDEVICE ON CALL — Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon Endo-Surgery’s global surgical stapler recall got Class I status from the FDA over concerns that issues with the devices’ firing mechanisms may injure patients.
HeartSine issues global correction of Samaritan defibrillators following deaths
U.K. medical device maker HeartSine Technologies launched a global correction of its Samaritan 300/300P public access defibrillators over concerns that the devices fail to provide life-saving shock therapy due to a pair of battery defects.
The devices have been loosely linked with 5 deaths that the company has not yet definitively deemed either related or unrelated to the battery issues, HeartSine reported.
Are thinner defibrillator leads more likely to fail? | MassDevice.com On Call
Recall: Ventlab pulls more than 14k defective manual respirators
Respiratory devices company Ventlab Corp. announced a nationwide recall of thousands of its manual resuscitators over concerns that the devices may not delivery enough or any air or oxygen to patients
The recall, which the company initially launched in July, affects more than 14,600 units across 12 different products, including the company’s RescueMed Infant Resuscitator and Premium Small Child Resuscitator, according to a press release.
FDA labels Accutron recall Class I over nitrous oxide leak that may harm patients
The FDA slapped Accutron’s recall of 206 flowmeters with Class I status, the agency’s designation for the most serious type of recall.
The agency warned that the flowmeters, which the company recalled earlier this month over leaking nitrous oxide, could lead to temporary or permanent brain damage or death.
Growing metal-on-metal hip controversy threatens to swallow more device makers
As the legal fallout over metal-on-metal hip implants continue to grow, the controversy threatens to swallow all MoM device makers, even those that have avoided a recall so far.
Report: St. Jude probed Riata problems in 2005
St. Jude Medical (NYSE:STJ) knew of potential problems with its Riata pacemaker lead, which it recalled in 2011, as early as 2005, according to FDA documents reviewed by the Wall Street Journal.
Accutron recalls 206 cabinet mount flowmeters over potential leak
Accutron recalled 206 units of its Ultra PC% cabinet mount flowmeters after receiving 2 reports that the devices leaked nitrous oxide after the oxygen flow was switched off.
When not accompanied by oxygen, the stream of nitrous oxide gas could cause brain damage in patients, the company noted.
The recall includes 8 product models and customers can return these flowmeters for free replacement, according to an FDA notice.
Recalls: Insurers look to recoup costs from faulty medical devices | Wall Street Beat
There were 113 Class I medical device recalls between 2005 and 2009, according to the Archives of Internal Medicine, meaning costly medical procedures and possible explantations for 10s of thousands of patients.
Insurance companies are increasingly looking to recoup those costs, Reuters reports, citing a 10-fold increase in mass tort cases over the last decade.