Waldemar Link Endo Model Knee Fusion Nail recalled for misaligned locking screw
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.
From the FDA notice · Read the official notice ↗ · All Waldemar Link recalls
What to do
- 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
Is yours affected?
Compare your label or packaging with 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.
- Sold in
- US distribution to states of: AL, GA, and TX.
- Made for
- Adults (0 months and older)
Details
- Units affected
- 18 units
- Illnesses reported
- None reported
- Manufactured in
- Oststr. 4-10, N/A, Norderstedt, N/A, Germany
- Classification
- Class II
- Recall number
- Z-0890-2026
In the FDA's words
- Description
- 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. 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. Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004; Distribution: US distribution to states of: AL, GA, and TX. Affected quantity: 18 units
- 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.
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ModerateFDAAug 19, 2026