Recall Z-2541-2025 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Waldemar Link GmbH & Co. KG (Mfg Site)
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
| Date | Sep 8, 2025 (initiated Jul 31, 2025) |
| Status | Open, Classified |
| Reason | Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect. |
| Root cause | Under Investigation by firm |
| Action | Waldemar Link notified consignees on about 07/31/2025 via URGENT: MEDCICAL DEVICE RECALL letter. Consignees were instructed to identify any affected units and arranging for their return to LinkBio Corporation, and to also complete and return the response form. |
| Quantity | 8 units |
| Distribution | Worldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the countries of Germany and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202924 | LinkSymphoKnee System Waldemar Link GmbH & Co. KG, May 13, 2021 |