FDA 483 - Zimmer, Inc. - June 20, 2013

Zimmer, Inc. in Warsaw, IN, received an FDA Form 483 citing multiple quality system deficiencies. The observations highlight inadequate corrective and preventive actions, unvalidated manufacturing and packaging processes, and failures in design control for their NexGen femoral implants. These issues have led to product quality problems such as implant residue and incompatible implant combinations, with potential for patient harm and revision surgeries.