FDA Device recall Z-0890-2026
Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12
- FDA Device
- Class II
- ongoing
- Published 2025-12-17
On 2025-12-17 the FDA classified a Class II recall of Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12 by Waldemar Link And Kg Mfg Site, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0890-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-10 |
| Published | 2025-12-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Waldemar Link And Kg Mfg Site |
| Distribution | AL, GA, TX |
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
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.
Identifiers
| code_info | Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0890-2026%22
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