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…

Recall date

November 10, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0890-2026

FDA classification

Class II

Brand / firm

Waldemar Link GmbH & Co. KG (Mfg Site)

Sold / distributed

US distribution to states of: AL, GA, and TX.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was 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.