Brian Buntz

March 12, 2013

2 Min Read
After Inspection, FDA Issues Warning Letter to Stryker

Stryker Corp. has announced that its instruments division has received a warning from the FDA following the agency's inspection of its facilities in Portage, MI in November 2012. The letter cited quality control issues and alleged that the company failed to notify the agency of a product recall. Furthermore, the letter stated that the company marketed devices, including the Neptune waste management system, for which it did not obtain regulatory clearance. The Neptune device is designed for use in the operating room to dispose of body fluids. Stryker has stated that it is now working to correct the problems mentioned in the letter. In September, the company announced that it had expanded the recall for several models of the Neptune Waste Management System, citing the lack of 510(k) clearance as the reason. Also last year, the company announced that it would lay off 1000 workers, citing the medical device tax as a reason. In receiving a warning letter from the FDA, Stryker joins the likes of medical device companies such as St. Jude Medical, Hospira, and Alere, all of which have received warning letters related to quality problems within the past six months. Incidentally, MD+DI featured a story on a company known as BioDrain Medical, which views FDA's warning letter regarding the Neptune Waste Management System as an opportunity. According to the firm's CEO, Josh Kornberg, the company's Streamway System surgical fluid waste management system would take market share from Stryker even without the warning letter citing the Neptune device. "But the warning letter is a fortunate issue for us," he says. For more news about Stryker, see:Stryker's FDA Troubles Equals Opportunity for Firm Selling Novel Waste Management DeviceStryker Completes Trauson Acquisition for $764 MillionMedtech Tax Leads to Layoffs for StrykerStryker Announces New Global Initiative

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