INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, REF 3604...
FDA Recall #Z-1410-2023 — Class II — February 16, 2023
Product Description
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, REF 3604532; 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
10 units
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
GTIN 00643169541856, Lot/Batch numbers: H5802984
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated