Recall Z-1649-2025 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Zimmer, Inc.
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
| Date | Apr 21, 2025 (initiated Mar 24, 2025) |
| Status | Open, Classified |
| Reason | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems. |
| Root cause | Under Investigation by firm |
| Action | Zimmer Biomet issued an URGENT MEDICAL DEVICE RECALL CORRECTION - PHASE 1 notice to its consignees on 03/24/2025 via email and courier. The notice explains the issue, potential risk, and requested the following: Distributors: Your Responsibilities 1. Review this notification and ensure that affected team members are aware of the contents. 2. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. 3. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com. a. Review the list of hospitals and/or surgeons i |
| Quantity | 160 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181171 | Zimmer Biomet Ceramic Heads Zimmer, Inc., Apr 2, 2019 |