Zimmer Biomet Updates: Product Supply Matters, Form 483

By Julie A. Vetalice

Zimmer Biomet reports that most product lines impacted by previously disclosed shipping delays have returned to full shipping capacity, and disclosed the receipt of a Form 483 following an FDA inspection of a legacy Biomet manufacturing site in Warsaw, Indiana.

No patient safety concerns have been identified with products manufactured at the site.

Sources: Zimmer Biomet, Inc.; ORTHOWORLD Inc.

Product Labels: Knee Replacement

Tags: Regulatory