Stryker Warned By FDA For Marketing Of Recalled Device

Law360, New York (March 12, 2013, 7:29 PM EDT) -- The U.S. Food and Drug Administration has sent a warning letter to Stryker Corp. for marketing a surgical waste removal device — which was recalled last year — without clearance from the agency, the company said Tuesday.

The agency faulted Stryker for marketing the Neptune Waste Management System and other devices without the required 510(k) approval for devices equivalent to an already-approved device, according to the company.

The letter also cited Stryker for failing to notify the FDA about a product recall and for quality system...
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