Medtronic Sofamor Danek USA Inc recalls INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034; for immobilization

Recalled April 26, 2023 · FDA recall Z-1413-2023 · Medtronic Sofamor Danek USA

Hazard

Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws · FDA Class II

Units

13 units

Sold at

Worldwide distribution - US Nationwide and the country of Canada.

Description

Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws

Product

INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3.

Manufacturer(s)

Medtronic Sofamor Danek USA Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →