Recall Z-0890-2026— Waldemar Link GmbH & Co. KG (Mfg Site)

Name: FDA recall Z-0890-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-10

Class II · Ongoing

Class II FDA medical device recall by Waldemar Link GmbH & Co. KG (Mfg Site), initiated 2025-11-10. It names one FDA 510(k) clearance: K151008. 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..

Recalling firm: Waldemar Link GmbH & Co. KG (Mfg Site)
Classification: Class II
Status: Ongoing
Initiated: 2025-11-10
Firm location: Norderstedt, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K151008 — LINK® MEGASYSTEM-C®Waldemar Link GmbH & Co. KG·cleared 2015-08-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.