Class IIReported 2026-03-18

Endo-Model Replacement Plateau; Item Number: 15-8521/09;

Recalled by Waldemar Link GmbH & Co. KG (Mfg Site)

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.

Recall Number

Z-1518-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2026-01-12

Reported

2026-03-18

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.

Code Info

Item Number: 15-8521/09; UDI-DI: 04026575383238; Serial/Lot Number: 250728/0038, 250728/0039, 250728/0040, 250728/0041, 250728/0042, 250728/0043, 250728/0044, 250728/0045;

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.