FDAHealthNovember 10, 2025
Waldemar Link GmbH & Co. KG (Mfg Site) — 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 device
⚠️ 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.
Is this relevant to me?
- Geography
- US, AL, GA, TX
- Source agency
- FDA
- Category
- Health
- Published
- November 10, 2025
US distribution to states of: AL, GA, and TX.
What's affected?
- 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.
- Lot code
- 2535004
Additional details
Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 18 units.
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