WhichRecall
Class IIReported 2025-12-17

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.

Recalled by Waldemar Link GmbH & Co. KG (Mfg Site)

Reason for Recall

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.

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Recall Number
Z-0890-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-11-10
Reported
2025-12-17
Distribution
US distribution to states of: AL, GA, and TX.
Code Info
Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004;
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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