Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;

Recalled March 18, 2026 · FDA recall Z-1514-2026 · Waldemar Link GmbH & Co. KG (Mfg Site)

Hazard

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

Units

31 units (OUS only)

Sold at

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.

Description

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

Product

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;

Manufacturer(s)

Waldemar Link GmbH & Co. KG (Mfg Site)

Made in

Germany

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →