Recall Z-1192-2018 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer Biomet, Inc.
Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced Neck Length; Part Number: 00-7711-004-10
| Date | Mar 14, 2018 (initiated Mar 1, 2018) |
| Status | Terminated |
| Reason | Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant. |
| Root cause | Labeling mix-ups |
| Action | RISK MANAGER: 1. Review this notification and notify affected personnel of the contents. 2. Quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. DISTRIBUTOR: 1. Review this notification and notify affected team members of the contents. 2. Quarantine affected product in your inventory. 3. Return affected product from your distributorship and from affected hospitals. a. Complete Inventory Return Certification Form and send t |
| Quantity | 24 |
| Distribution | Distributed in the following U.S. states: AZ, CA, CT, IN, MD, MI, MN, NJ, NY, OR, WA, and Puerto Rico. Distributed in China and India. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060040 | ZIMMER M/L TAPER HIP PROSTHESIS Zimmer, Inc., May 12, 2006 |