FDA Medical devices recall ·
Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component… recall
- Recall number
- Z-0890-2026
- Date
- (initiated November 10, 2025)
- Company / brand
- Waldemar Link GmbH & Co. KG (Mfg Site)
Oststr. 4-10, Norderstedt, N/A, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 18 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004;
Distribution
US distribution to states of: AL, GA, and TX.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0890-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.