Class II

Medical Device Recall: 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.

Waldemar Link GmbH & Co. KG (Mfg Site) · November 10, 2025

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.

Distribution

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

States Affected

AL, GA, TX

Quantity Affected

18 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0890-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.