Drug recall
Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12…
FDA recall event 97971 · Class II · Waldemar Link GmbH & Co. KG (Mfg Site)
Key facts
| Event ID | 97971 |
|---|---|
| Recall numbers | Z-0890-2026 |
| Recalling firm | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Product type | Devices |
| 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. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Nov 10, 2025 |
| Report date | Dec 17, 2025 |
| City | Norderstedt |
| Country | Germany |
| FEI number | 3003386935 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: