FDA-Device2025-12-17Class IIPROCESSING DEFECT
Waldemar Link Endo Model Knee Fusion Nail recalled for misaligned locking screw
Check Waldemar Link knee fusion nail implant
Waldemar Link knee fusion nails in certain lots were shipped with a locking screw installed incorrectly—inserted from the wrong side into the femoral component. This misalignment could affect how the device functions after implantation. Eighteen units were distributed to Alabama, Georgia, and Texas.
- If you received this implant, contact your surgeon immediately with the item number 15-0028/08 and lot number 2535004
- Do not use any affected units still in inventory
- Surgeons should review patient records to identify anyone who received this device and discuss next steps
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-0890-2026More Waldemar Link GmbH & Co. KG (Mfg Site) recalls
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