INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; 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.
Reported: April 26, 2023 Initiated: February 16, 2023 #Z-1409-2023
Product Description
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; 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
Details
- Recalling Firm
- Medtronic Sofamor Danek USA Inc
- Units Affected
- 45 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; 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.. Recalled by Medtronic Sofamor Danek USA Inc. Units affected: 45 units.
Why was this product recalled? ▼
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 26, 2023. Severity: Moderate. Recall number: Z-1409-2023.
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