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FDA warns Stryker on quality issues, marketing practices

9:06 am by | 0 Comments

(Reuters) - 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.

Stryker shares were down about 0.5 percent at $65.90 in premarket trading.

(Reporting by Esha Dey in Bangalore; Editing by Joyjeet Das)

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