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Recall Observatory FDA recall evidence

Device 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.

Z-0890-2026

November 10, 2025

Class II

Product summary

Firm
Waldemar Link GmbH & Co. KG (Mfg Site)
Event
Event 97971
Status
Ongoing
Classification
Class II
Quantity
18 units
Official record key
device-enforcement:Z-0890-2026

Official wording

Reason: 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.

Code information: Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004;

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.