Integra LifeSciences recall affects Medtronic's Infuse kits

July 2, 2013 by Arezu Sarvestani

Integra Lifesciences recalls certain lots of its surgical sponges, including some that were packaged with Medtronic's Infuse bone graft kits.

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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.

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"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.

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