Waldemar Link GmbH & Co. KG (Mfg Site): Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;

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: 49 units (OUS only) Lot/code info: Item Number: 16-2840/02; UDI-DI: 04026575359233; Serial/Lot Number: 250925/0640 , 250925/0641, 250925/0642, 250925/0646, 250925/0650, 250925/0652, 250925/0653 , 250925/0656, 250925/0658, 250925/0669, 250925/0670, 250925/0680, 250925/0681 , 250925/0682, 250925/0687, 250925/0689, 250925/0690, 250925/0691, 250925/0693 , 250925/0694, 251110/3293, 250925/0660, 250925/0661, 250925/0684, 250925/0685 , 250925/0657, 250925/0663, 250925/0659, 250925/0678, 251110/3288, 251110/3292 , 251110/3303, 251110/3313, 250925/0683, 250925/0674, 250925/0644, 250925/0665 , 250925/0668, 250925/0671, 250925/0673, 250925/0676, 250925/0664 , 250925/0651 , 251110/3297, 251110/3289, 250925/0639, 250925/0648, 250925/0688, 250925/0696;

UPC codes

04026575359233

Source

Official record: FDA (Device enforcement) ↗

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