Waldemar Link GmbH & Co. KG (Mfg Site): Medical Device Recall in 2025 - (Recall #: Z-0890-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 10, 2025

Date Posted: December 17, 2025

Recall Number: Z-0890-2026

Event ID: 97971

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.

Status: Ongoing

Product Quantity: 18 units

Code Information:

Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004;

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated