Class II

Medical Device Recall: Endo-Model Replacement Plateau; Item Number: 15-0027/16;

Waldemar Link GmbH & Co. KG (Mfg Site) · January 12, 2026

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.

Distribution

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.

States Affected

NATIONWIDE

Quantity Affected

3 units (OUS only)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1523-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.