FDA Warns Stryker on Quality Issues

FDA Warns Stryker on Quality Issues

March 12th, 2013 // 3:58 pm @

Orthopedic implant maker Stryker Corp said it received a warning letter from the U.S. Food and Drug Administration related to quality concerns at its Portage, Michigan facility.

The letter also said Stryker failed to notify the regulator of a product recall, and had been marketing devices without approval.

The FDA acknowledged that Stryker has submitted corrective action plans for the quality and recall issues, Stryker said.

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