Endo Model Knee Fusion Nail SK — Class II medical device recall Z-0890-2026
Ongoing recall by Waldemar Link GmbH & Co. KG (Mfg Site), reported 2025-12-17, distributed in AL, GA, TX. The device has been delivered with a preassembled locking screw that had been inserted from the wrong side int
| Recall number | Z-0890-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt, N/A, Germany |
| Recall initiated | 2025-11-10 |
| Classified | 2025-12-09 |
| Reported by FDA | 2025-12-17 |
| Distributed | AL, GA, TX |
| Quantity | 18 units |
| UPC / GTIN / UDI-DI | 04026575175222 |
| Lot numbers | 2535004 |
| Model numbers | 15-0028/08 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0890-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.