Class IIReported 2026-03-18

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

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-1523-2026

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: 15-0027/16; UDI-DI: 04026575432134; Serial/Lot Number: 2550412, 2550413, 2549228;

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