Tibial Component. orthopedic prosthesis. Model Nos: Small, W 16-2817/02 Medium, W 16-2817/05 Large, W 16-2817/07
Check against the official notice below — it lists the full affected range.
Waldemar Link GmbH & Co. KG is recalling 3,785 tibial component orthopedic prostheses in small, medium, and large sizes due to a risk that blind screws of the modular tibial component cannot be loosened during surgery. This defect may cause surgery to be prolonged if the procedure needs to be changed intraoperatively. The affected devices were distributed domestically across 20 U.S. states and internationally to numerous countries.
The recall involves specific lot and serial numbers associated with the recalled devices, identified by their UDI-DI codes. The source document does not specify a remedy or corrective action for consumers who have received or may be affected by these recalled devices.
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: 04026575359202 Small, W; 04026575359219 Medium, W; 04026575359226 Large, W; Serial/Lot Numbers: 201002/1683 211025/1543 210202/0275 210302/0308 210314/1872 201002/1687
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.