FDA Sends Warning Letter to Stryker Corp. on Quality Issues, Marketing Practices and Failure to Notify Agency of RecallMar 12, 2013
The U.S. Food and Drug Administration (FDA) has sent a warning letter to Stryker Corporation, an orthopedic implant manufacturer, over quality concerns at its Portage, Michigan, manufacturing facility.
The warning letter followed an inspection of the Stryker facility in November 2012, Reuters reports. In addition to the quality system issues, the letter also said that Stryker had failed to notify the FDA of a product recall and had been marketing some devices, including the Neptune Waste Management System, without required approvals. In a March 13, 2013 press release, Stryker that it is cooperating with the FDA to resolve the issues in a “comprehensive and timely manner.” The company also said that it had submitted corrective action plans for the quality system and recall issues and the FDA had acknowledged these actions.
The Neptune Waste Management product line and certain hip implant products were part of a series of recalls Stryker made last year, Reuters reports. The Neptune recall was deemed a Class I, the most serious FDA designation. By FDA definition, a Class I recall involves situations in which there is a reasonable probability that use of the recalled products will cause serious adverse health consequences or death. Stryker had received two reports of serious injury, including one fatality, according to the recall notice posted on the FDA website in September 2012.
The Neptune Waste Management System is intended to collect and dispose of surgical fluid waste in operating rooms and surgical facilities, Reuters said.