Waldemar Link GmbH & Co. KG (Mfg Site): Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;

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: 31 units (OUS only) Lot/code info: Item Number: 16-2840/07; UDI-DI: 04026575359257; Serial/Lot Number: 250925/0480 , 250925/0481, 250925/0482, 250925/0483, 250925/0484, 250925/0486, 250925/0489 , 250925/0491, 250925/0492, 250925/0494, 250925/0503, 250925/0504, 250925/0345 , 250925/0346, 250925/0349, 250925/0350, 250925/0351, 250925/0352, 250925/0356 , 250925/0369, 250925/0501, 250925/0365, 250925/0368, 250925/0490, 250925/0488 , 250925/0479, 250925/0495, 250925/0500, 250925/0496, 250925/0499, 250925/0367;

UPC codes

04026575359257

Source

Official record: FDA (Device enforcement) ↗

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