Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, ...
FDA Recall #Z-0890-2026 — Class II — November 10, 2025
Product Description
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.
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.
Recalling Firm
Waldemar Link GmbH & Co. KG (Mfg Site) — Norderstedt, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
18 units
Distribution
US distribution to states of: AL, GA, and TX.
Code Information
Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.