FDA (Devices) recall action 90477
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
FDA recalls certain Endo Model orthopedic implants because the blind screws may not loosen during surgery, potentially requiring surgeons to change their approach and prolonging the procedure.
Waldemar Link is recalling Endo Model Modular Femur and Tibia orthopedic prostheses because the blind screws on the tibial component cannot be loosened during surgery, potentially prolonging procedures.
Tibial prosthesis components may have blind screws that cannot be loosened during surgery, potentially requiring surgical procedure changes and extended operative time.
Tibial prosthetic components have defective blind screws that may not loosen during surgery, requiring procedure changes. Approximately 3,785 units of models W 16-2817/32, 35, and 37 were distributed across the US and internationally.