INFINITY Occipitocervical Upper Thoracic System — Class II medical device recall Z-1412-2023
Ongoing recall by Medtronic Sofamor Danek USA Inc, reported 2023-04-26, distributed nationwide. Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infi
| Recall number | Z-1412-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Sofamor Danek USA Inc, Memphis, TN, United States |
| Recall initiated | 2023-02-16 |
| Classified | 2023-04-19 |
| Reported by FDA | 2023-04-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 90 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00643169554696 |
| Lot numbers | H5806345 |
| Model numbers | 3604026 |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1412-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.