Recall Z-1702-2025 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Waldemar Link GmbH & Co. KG (Mfg Site)
Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-331/22 (Sz. 1-2 - cemented x-lg), (6) 880-331/23 (Sz. 1-2 - cemented xx-lg), (7) 880-333/11 (Sz. 3-4 - cemented x-sm), (8) 880-333/12 (Sz. 3-4 - cemented sm), (9) 880-333/13 (Sz. 3-4 - cemented md), (
| Date | Apr 30, 2025 (initiated Apr 3, 2025) |
| Status | Open, Classified |
| Reason | The device was delivered with a preassembled Femoral Augment screw that was missing its thread. |
| Root cause | Nonconforming Material/Component |
| Action | On April 3, 2025 URGENT: MEDICAL DEVICE CORRECTION letters were emailed to customers. Actions to be taken by the Customer/User: Please take note of the following instructions for replacing any screws found missing the thread. No product return is required. Instructions for disassembling and replacing a defective screw: Disassembly 1. Use the 2.5 mm Torque Wrench article REF (15-2545) to unscrew the screw from the Augment while pushing the tip of the screw towards the Augment. 2. Exchange the screw. Open an alternative Augment and use its screw. Alternative sizes of Augments are always availab |
| Quantity | 1771 units |
| Distribution | US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IN, IL, KS, LA, MD, MO, NV, OH, TX, VA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202924 | LinkSymphoKnee System Waldemar Link GmbH & Co. KG, May 13, 2021 |