Stryker Issued FDA Warning for Dangerous Product

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Stryker Corp due to a quality systems-related issue at the Portage, Michigan facility – where products from Stryker’s Instruments are produced – and the company’s marketing of unapproved medical devices including the Neptune Waste Management system.

Stryker issued a Class 1 recall of the Neptune system in June 2012, weeks before it also recalled the Stryker Rejuvenate and ABG II metal-on-metal hip implants after the devices were showing substantial rates of hip implant failure. The Neptune system, which collects surgical waste fluids and evacuates smoke during clinical procedures, was causing severe injuries, one of which resulted in death.

Stryker received the warning in response to its marketing products without adequate regulatory approval and failing to inform the FDA about the product recall.

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