FDA Cites Orthopedic Medical Device Company Extremity Medical Over Violations

Published: Apr 25, 2012

The U.S. Food and Drug Administration has cited several violations by an orthopedic medical devices startup that produces implants and screws used for orthopedic surgery on hands, wrists, feet and ankles in a warning letter to the company. Among the infractions by Extremity Medical cited in the warning letter dated Feb. 24 were two cases in which the company failed to submit a product experience report to the U.S. regulator after it became aware that a device it markets may have caused or contributed to a death or serious injury.

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