XTANT Medical Recall 89367
Description: X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
XTANT Medical Recall 89367 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0533-2022 |
| Event ID | 89367 |
| Event Description | X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System. |
| Product Type | Devices |
| Distribution | U.S.: CA, MI, NV, and TX O.U.S.: Portugal |
| Quantity | 24 devices |
| Recall 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. |
| Device Classification | 20220209 |
| Device Code Info | X060-0270, 8mm Titanium Insert, Axle System UDI (Primary DI Number): M697X06002701/$$7058963W Lot Number: 058963 |
| Center Classification Date | 20220128 |
| Recall Initiation Date | 20211229 |
| Recalling Firm | XTANT Medical |
| Initial Notification | Letter |
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