Medtronic Sofamor Danek USA Inc Recall 91790
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.
Medtronic Sofamor Danek USA Inc Recall 91790 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1409-2023 |
| Event ID | 91790 |
| Event 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. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| Quantity | 45 units |
| Recall Reason | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws |
| Device Classification | 20230426 |
| Device Code Info | GTIN 00643169554689, Lot/Batch numbers: H5802983 |
| Center Classification Date | 20230419 |
| Recall Initiation Date | 20230216 |
| Recalling Firm | Medtronic Sofamor Danek USA Inc |
| Initial Notification | Letter |
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