Recall Z-0432-2026 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Total Joint Orthopedics, Inc.
Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic BiPolar Head, 42 mm OD, 22 mm Head; 3205.43.022 Klassic BiPolar Head, 43 mm OD, 22 mm Head; 3205.44.028 Klassic BiPolar Head, 44 mm OD, 28 mm Head; 3205.45.028 Klassic BiPolar Head, 45 mm OD, 28 mm Head; 3205.46.028 Klassic BiPolar Head, 46 mm OD, 28 mm Head; 3205.47
| Date | Nov 5, 2025 (initiated Sep 23, 2025) |
| Status | Open, Classified |
| Reason | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted. |
| Root cause | Packaging |
| Action | On September 5, 2025 Total Joint issued customer a Field action notification. On September 23, 2025, Total Joint issued a Urgent Medical Device Recall Notification. Total Joint ask consignees to take the following actions: 1. Stop implanting the affected product. 2. Locate and quarantine all affected inventory. 3. With preliminary info we initially sent a Market Withdrawal notification on 9/05/2025 to initiate the quarantining and return of all BiPolar Heads in your possession. 4. A list of all BiPolar Heads in your possession as of 9/05/2025 is shown within the letter, if you have alread |
| Quantity | 103 units |
| Distribution | US Nationwide distribution in the states of Ohio, Texas, Florida, Georgia, and North Carolina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143113 | Klassic BiPolar System Total Joint Orthopedics, Jan 28, 2015 |