Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model Replacement Plateau; Item Number: 15-8030/12;

Recall date

January 12, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1517-2026

FDA classification

Class II

Brand / firm

Waldemar Link GmbH & Co. KG (Mfg Site)

Sold / distributed

Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Endo-Model Replacement Plateau; Item Number: 15-8030/12;