Recall Z-1294-2023 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer, Inc.
CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item Number: 01.01012.384
| Date | Mar 29, 2023 (initiated Feb 27, 2023) |
| Status | Open, Classified |
| Reason | Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in flexion/extension being less than 100 degrees as recommended per an internationally recognized standard (ISO 21535:2009 |
| Root cause | Under Investigation by firm |
| Action | Zimmer Biomet issued Urgent Medical Device Correction letter on 2/27/23 via Fed'X .Letter to Distributors, Doctors, Risk Managers and states reason for recall, health risk and action to take: Hospital Responsibilities: 1. Review this field action notice and ensure that affected personnel are aware of the contents. 2. Complete Attachment 1 Certificate of Acknowledgement Form and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. 3. Retain a copy of the Attachment 1 Certificate of Acknowledgement Form w |
| Quantity | 1,168 untits |
| Distribution | AL AZ CO FL LA MI OH OK TX Foreign: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993259 | INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS Sulzer Orthopedics, Inc., Mar 10, 2000 |