Recall Z-2365-2018 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer Biomet, Inc.
Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 10; 00-7713-010-00
| Date | May 30, 2018 |
| Status | Terminated |
| Reason | |
| Root cause | Packaging |
| Action | On May 30, 2018, the firm emailed Urgent Medical Device Recall letters to its Japanese subsidiary, who then further distributed the letters locally to Distributors and Risk Managers in Japan. The letter informed affected consignees of the product issue. Customers were instructed to do the following: Distributor Responsibilities: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals with |
| Quantity | 24 |
| Distribution | Products were distributed solely to Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063251 | ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY Zimmer, Inc., Jan 24, 2007 |