Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, Small, Left 15-3816/12, Medium, Right 15-3817/11, Medium, Left 15-3817/12, Large, Right 15-3818/11.
Check against the official notice below — it lists the full affected range.
Waldemar Link GmbH & Co. KG is recalling 3,785 units of Endo Model Modular Femur and Tibia PorEx orthopedic prosthesis components in various sizes because blind screws on the modular tibial component may not loosen during surgery. This defect could require surgeons to change their surgical procedure, potentially extending operating time. The affected devices were distributed domestically across 15 U.S. states and internationally to numerous countries.
The recall affects specific lot and serial numbers manufactured between May 2020 and March 2021. Affected devices can be identified by their UDI-DI codes and serial/lot number information provided in the recall notice. The source document does not specify a remedy or recommended action for 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 04026575034727 X-Small, Right; 04026575034741 Small, Right; 04026575034758 Small, Left; 04026575164042 Medium, Right; 04026575164059 Medium, Left; 04026575164028 Large, Right; Serial/Lot Numbers: 200818/1709 200818/1720 201013/0291 200513/2160 200818/1732 200623/4154 200812/1511 210302/2440
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.