Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37
Check against the official notice below — it lists the full affected range.
Waldemar Link GmbH & Co. KG is recalling 3,785 modular tibial components used in orthopedic prosthesis procedures across three sizes (small, medium, and large). The recalled components were distributed domestically to 15 U.S. states and internationally to 30 countries. The hazard involves blind screws that may not loosen during surgery, which could extend surgical time and require changes to the surgical procedure.
The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. 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 Quantity: 3785 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.