Waldemar Link GmbH & Co. KG (Mfg Site): Endo-Model Replacement Plateau; Item Number: 15-8521/09;

Hazard

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

Details from the source

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. Quantity: 8 units (OUS only) Lot/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;

UPC codes

04026575383238

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.