FDA-Device2023-04-26Class II
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.
Medtronic Sofamor Danek USA Inc
Hazard
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
10 units
Manufactured in
1800 Pyramid Pl, N/A, Memphis, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1410-2023Don't want to check this manually?
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