Recall Z-2640-2025 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Howmedica Osteonics Corp.
1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;
| Date | Sep 26, 2025 (initiated Aug 28, 2025) |
| Status | Open, Classified |
| Reason | a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted. |
| Root cause | Under Investigation by firm |
| Action | On August 28, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions Needed: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form. |
| Quantity | 55 units (all OUS) |
| Distribution | International distribution in the country of United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup Howmedica Osteonics Corp., Aug 13, 2020 |