Waldemar Link GmbH & Co. KG (Mfg Site): Device Recall

Recall #Z-0890-2026 · 11/10/2025

Class II: Risk

Recall Details

Recall Number: Z-0890-2026
Classification: Class II
Product Type: Device
Recalling Firm: Waldemar Link GmbH & Co. KG (Mfg Site)
Status: Ongoing
Date Initiated: 11/10/2025
Location: Norderstedt, N/A, Germany
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 18 units

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.

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.

Distribution Pattern

US distribution to states of: AL, GA, and TX.

Other Recalls by Waldemar Link GmbH & Co. KG (Mfg Site)

Class II: Risk 07/31/2025

Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
Class II: Risk 07/15/2025

Inconsistent size terminology and color coding used on labeling
Class II: Risk 07/15/2025

Inconsistent size terminology and color coding used on labeling
Class II: Risk 04/03/2025

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Class II: Risk 04/03/2025

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

View all recalls by Waldemar Link GmbH & Co. KG (Mfg Site) →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.