Recall Z-1517-2026— Waldemar Link GmbH & Co. KG (Mfg Site)

Name: FDA recall Z-1517-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-12

Class II · Ongoing

Class II FDA medical device recall by Waldemar Link GmbH & Co. KG (Mfg Site), initiated 2026-01-12. It names one FDA 510(k) clearance: K151008. Product: Endo-Model Replacement Plateau; Item Number: 15-8030/12;. Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture..

Recalling firm: Waldemar Link GmbH & Co. KG (Mfg Site)
Classification: Class II
Status: Ongoing
Initiated: 2026-01-12
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 Replacement Plateau; Item Number: 15-8030/12;

Reason for recall

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

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