Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo
- Recalling company
- Waldemar Link GmbH & Co. KG (Mfg Site)
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Nov 10, 2025
- Reported
- Dec 17, 2025
- Distribution
- US distribution to states of: AL, GA, and TX.
- Status
- Ongoing
- Quantity
- 18 units
- Lot / codes
- Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004;
- Company location
- Norderstedt, N/A
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0890-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0890-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.