Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Tap
Pending LLM rewrite. Source: FDA_DEVICE Z-0890-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- 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.
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Item Number: 15-0028/08
- UDI-DI: 04026575175222
- Lot Number: 2535004
Distribution
Distributed in 3 states:
- AL
- GA
- TX
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