FDA 483 - Zimmer, Inc. - May 21, 2012

Zimmer, Inc., a medical device manufacturer in Warsaw, IN, was cited for multiple significant quality system deficiencies during an FDA inspection. The firm failed to control nonconforming products, specifically distributing radiographically undetectable femoral heads for hip replacement surgery without proper identification or disposition. Additionally, the inspection revealed inadequate corrective and preventive action procedures, unmaintained device master records, unvalidated critical manufacturing processes, and a failure to report device corrections and removals to the FDA, all of which pose potential risks to patient health.