Z-1412-2023 Class II Ongoing
FDA device recall Z-1412-2023 was initiated by Medtronic Sofamor Danek USA Inc on February 16, 2023 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 90 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2023
- Initiation Date
- February 16, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 90 units
Product Description
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026; 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
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
GTIN 00643169554696, Lot/Batch numbers: H5806345