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Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee compo
Recalled December 17, 2025 · FDA recall Z-0890-2026 · Waldemar Link GmbH & Co. KG (Mfg Site)
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. · FDA Class II
Units
18 units
Sold at
US distribution to states of: AL, GA, and TX.
Description
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.
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.
Manufacturer(s)
Waldemar Link GmbH & Co. KG (Mfg Site)
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →