Recall Z-0673-2022 ยท MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Biomet, Inc.
Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM, 55 MM Long Item Number: 113618
| Date | Jan 7, 2022 |
| Status | Terminated |
| Reason | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor. |
| Root cause | Process control |
| Action | Zimmer Biomet issued Urgent Medical Device Recall Letter (ZFA 2021-00267) to Distributors, Risk Managers, and Surgeons on January 7, 2022 via FedEx. For US and OUS distributors, the notification was completed via email . Letter states reason for recall, health risk and action to take: Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the a |
| Quantity | 12 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Ecuador, Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.