Recall Z-0939-2018 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer Biomet, Inc.
Trabecular Metal Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20 (UDI: (01) 00889024139268 (17) 250731 (10) 63703681)
| Date | Jan 3, 2018 |
| Status | Terminated |
| Reason | Two lots of hip implants are mislabeled. |
| Root cause | Labeling mix-ups |
| Action | DISTRIBUTORS: 1. Review this notification and notify affected team members of the contents. 2. Immediately locate and quarantine affected product. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. Mark RECALL on the outside of the returned cartons. 4. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com RISK MANAGERS: 1. Review this notification and notify affected per |
| Quantity | 24 |
| Distribution | Distributed in 2 US states: LA and NY. Distributed in Canada, China, Japan, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051491 | TRABECULAR METAL PRIMARY HIP PROSTHESIS Zimmer, Inc., Jun 30, 2005 |