Waldemar Link GmbH & Co. KG (Mfg Site) Recall 90477
Description: Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37
Waldemar Link GmbH & Co. KG (Mfg Site) Recall 90477 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1380-2022 |
| Event ID | 90477 |
| Event Description | Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37 |
| Product Type | Devices |
| 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 Libya Lithuania Mexico Netherlands Norway Pakistan Peru Philippines Poland Romania Saudi Arabia Slovakia Slovenia Spain Sudan Sweden Switzerland Thailand Turkey Ukraine United Arab Emirates Uruguy Vietnam |
| Quantity | 3785 |
| Recall 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. |
| Device Classification | 20220720 |
| Device Code Info | UDI-DI: 04026575370870 Small, W; 04026575370887 Medium, W; 04026575370894 Large, W; Serial/Lot Numbers: 210308/0020 210308/0035 210222/0789 151116/4741 |
| Center Classification Date | 20220712 |
| Recall Initiation Date | 20220524 |
| Recalling Firm | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Initial Notification | |
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