Class IIReported 2026-03-18

Endo-Model Replacement Plateau; Item Number: 15-8521/11;

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-1519-2026

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: 15-8521/11; UDI-DI: 04026575383245; Serial/Lot Number: 250728/2220, 250728/2222, 250728/2223, 250728/2224, 250728/2225, 250728/2226, 250728/2227;

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