medical Class II Updated 2022-07-20

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

Recalled Product

Tibial Component. orthopedic prosthesis. Model Nos: Small, W 16-2817/02 Medium, W 16-2817/05 Large, W 16-2817/07


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: 04026575359202 Small, W; 04026575359219 Medium, W; 04026575359226 Large, W; Serial/Lot Numbers: 201002/1683 211025/1543 210202/0275 210302/0308 210314/1872 201002/1687
View official government recall

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