FDA Closes Warning Letter for Zimmer Biomet China Facility

By Julie A. Vetalice

FDA notified Zimmer Biomet that a Warning Letter dated June 3, 2015 relating to its Zhejiang, China manufacturing facility has been closed out.

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.

Product Labels: Knee Replacement

Tags: Regulatory