Recall Z-1377-2022 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Waldemar Link GmbH & Co. KG (Mfg Site)
Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.
| Date | May 24, 2022 |
| Status | Open, Classified |
| Reason | There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure. |
| Root cause | Nonconforming Material/Component |
| Action | On May 24, 2022, the firm notified affected customers via Urgent Field Safety Notice email. Customers were provided a modified surgical technique providing information for the cementing technique for Tilastan proximal spacers to minimize the risk. No product return is required. |
| Quantity | 3785 |
| Distribution | Domestic distribution to AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA. Foreign distribution to Algeria Argentina Australia Austria Belgium Bulgaria Canada China Colombia Denmark Ecuador Estonia Finland France Germany Great Britain Greece Hungary India Indonesia Israel Italy Latvia Liby |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212742 | GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating Waldemar Link GmbH & Co. KG, Sep 16, 2021 |