Class II — XTANT Medical
| Recalling firm | Xtant Medical Holdings, Inc. |
|---|---|
| Registered facility | Xtant Medical Holdings, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System. |
| Quantity | 24 devices |
| Distribution | U.S.: CA, MI, NV, and TX O.U.S.: Portugal |
| Initiated | 2021-12-29 |
| Classified | 2022-01-28 |
| Terminated | 2024-06-17 |
| Recall number | Z-0533-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — XTANT Medical (Z-0533-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89367/
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