United StatesEndo Model Knee Fusion Nail SK knee fusion nail coupling component (right, modular, L=68 mm, Taper 10/12; Item Number 15-0028/08; UDI‑DI 04026575175222; Lot 2535004) sold in AL, GA, and TX (18 units). It was recalled because the device was delivered with a preassembled locking screw inserted from the wrong side into the male taper of the femoral component.
What's being recalled
Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
Recalling firm: Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt, N/A, Germany.
How to identify it
Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004;
The hazard
The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US distribution to states of: AL, GA, and TX.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)