The facility manufactures orthopaedic surgical instruments used with knee prosthesis systems. Noted violations related to:
- ~1,051 of 1,654 3.5mm Inserter Connector pieces manufactured and shipped between 11/10 and 3/13 without meeting the minimum required tensile strength; company received ~45 complaints of tip fracture for the device
- Establishment of procedures for monitoring validated processes
- Nonconformances that were not adequately analyzed or investigated
- Identification of seven work orders that did not record rinse/solution changes
- Failure to base sampling plans on a valid statistical rationale
Source: Zimmer Biomet, Inc.