X060-0270 — Class II medical device recall Z-0533-2022
Terminated recall by XTANT Medical, reported 2022-02-09, distributed in CA, MI, NV, TX. The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar
| Recall number | Z-0533-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | XTANT Medical, Belgrade, MT, United States |
| Recall initiated | 2021-12-29 |
| Classified | 2022-01-28 |
| Reported by FDA | 2022-02-09 |
| Terminated | 2024-06-17 |
| Distributed | CA, MI, NV, TX |
| Countries outside the US | PT |
| Quantity | 24 devices |
| Reason classes | specification failure |
| Lot numbers | 058963 |
Product
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
Reason for recall
The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
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-0533-2022. 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.