Z-0890-2026 Class II Ongoing
FDA device recall Z-0890-2026 was initiated by Waldemar Link GmbH & Co. KG (Mfg Site) on November 10, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 18 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 17, 2025
- Initiation Date
- November 10, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 units
Product Description
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.
Distribution Pattern
US distribution to states of: AL, GA, and TX.
Code Information
Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004;