INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0...
FDA Recall #Z-1411-2023 — Class II — February 16, 2023
Product Description
INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, REF 360PT4022; 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.
Reason for Recall
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Recalling Firm
Medtronic Sofamor Danek USA Inc — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2 units
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
GTIN 00643169552654, Lot/Batch numbers: H5806333
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated