FDA Device recall Z-0533-2022
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System
- FDA Device
- Class II
- terminated
- Published 2022-02-09
On 2022-02-09 the FDA classified a Class II recall of X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System by Xtant Medical, citing the proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0533-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-29 |
| Published | 2022-02-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Xtant Medical |
| Distribution | CA, MI, NV, TX |
Product
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
Reason
The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
Identifiers
| code_info | X060-0270, 8mm Titanium Insert, Axle System UDI (Primary DI Number): M697X06002701/$$7058963W Lot Number: 058963 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0533-2022%22
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