FDA-Device2025-12-17Class II
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.
Waldemar Link GmbH & Co. KG (Mfg Site)
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.
Sold states
US distribution to states of: AL, GA, and TX.
Affected count
18 units
Manufactured in
Oststr. 4-10, N/A, Norderstedt, N/A, Germany
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0890-2026Don't want to check this manually?
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