medical Class II Updated 2022-07-20

Waldemar Link GmbH & Co. KG (Mfg Site) recalls Tibial Component Modular. orthopedic prosthesis. Model Nos:

Recalled Product

Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37

Hazard / Issue

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.

Issued by

FDA

Affected States: AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA
Lot/Code Info: UDI-DI: 04026575370870 Small, W; 04026575370887 Medium, W; 04026575370894 Large, W; Serial/Lot Numbers: 210308/0020 210308/0035 210222/0789 151116/4741
View official government recall

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