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

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

Code information: 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;

Distribution pattern: 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.