Recall Z-2371-2024 ยท KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Howmedica Osteonics Corp.
UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042
| Date | Jul 16, 2024 (initiated Jun 19, 2024) |
| Status | Open, Classified |
| Reason | Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm) |
| Root cause | Employee error |
| Action | Stryker issued Urgent Medical Device Recall (UMDR) PFA 3585464 third party Sedgwick on June 19, 2024, via UPS 2-day air. Letter states reason for recall, health risk and action to take: 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 produ |
| Quantity | 18 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K014226 | UNITRAX MODULAR UNIPOLAR SYSTEM Howmedica Osteonics Corp., Jan 25, 2002 |