FDA recall Z-0890-2026

Waldemar Link GmbH & Co. KG (Mfg Site) · Class II · device

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 for recall

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.

Distribution

US distribution to states of: AL, GA, and TX.

Key facts

Status
Ongoing
Initiation date
2025-11-10
Report date
2025-12-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Norderstedt, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0890-2026