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
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Waldemar Link GmbH & Co. KG (Mfg Site)
- 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.
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US distribution to states of: AL, GA, and TX.
- Recall initiated
- 2025-11-10
- Code info
- Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004;
- Product quantity
- 18 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Norderstedt
- State
- N/A
- Country
- Germany
- Event id
- 97971
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