Device product
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.
Z-0890-2026
Product summary
- Event
- Event 97971
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18 units
- Official record key
device-enforcement:Z-0890-2026
Official wording
Reason: 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.
Code information: Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004;
Distribution pattern: US distribution to states of: AL, GA, and TX.
Derived failure modes
-
Unknown
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.