Integra initiated the voluntary recall after an internal investigation found endotoxin testing deviations. The deviations may have resulted in the release of medical devices with levels of endotoxins that exceed the levels permitted by the product specifications, the company said. Endotoxins can cause immune responses that result in postoperative fever.
The company has “no specific indication of any reported product complaints related to high endotoxin levels” but the risk of harm led it to start recalling products and extend a temporary halt on production at the facility. Integra will use the time to “implement additional detection and quality controls,” according to the company.