Minnesota medical device giant Medtronic (NYSE:MDT) confirmed today that it recalled certain of its already-troubled Infuse spinal fusion surgery kits after learning of possible contamination in sponges manufactured by Integra Lifesciences.
Integra notified Medtronic on April 11, 2013, of possible endotoxin contamination in certain lots of its absorbable collagen sponges, including some that were included in the Infuse/LT-Cage bone graft kits, used in spinal fusion procedures, according to a Medtronic statement.
"Patient safety is our top priority, and we have been assured that all of the product involved in this voluntary recall is sterile and met Integra LifeSciences’ finished goods test requirements when it was released," according to the company.
Australia’s Therapeutics Good Administration issued a "recall and hazard alert" on the recall, noting that have been no reports of adverse events associated with the potentially toxic sponges in Australia or overseas.
Medtronic’s Infuse product light has been fraught with controversy for the couple of years, at times included allegations of off-label marketing and concealed health risks for patients implanted with the bone morphogenetic protein. The story blew up over the summer of 2011 when the Spine Journal dedicated its entire June issue (PDF) to exposing problems with growth proteins, including a repudiation of some of the research surrounding Infuse.
The Infuse bone growth protein has been on the U.S. market since 2002, when the FDA approved the product for use in the lower spine. Lawsuits have accused Medtronic of illegally marketing the device for use in the neck, but a years-long criminal and civil investigation closed in May 2012 without finding evidence of wrongdoing.
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