[pending] 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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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