Class II — XTANT Medical Holdings, Inc
| Recalling firm | Xtant Medical Holdings, Inc. |
|---|---|
| Registered facility | Xtant Medical Holdings, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is. |
| Product | XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL. |
| Quantity | 2 units |
| Distribution | US: OR |
| Initiated | 2026-02-18 |
| Classified | 2026-04-03 |
| Recall number | Z-1773-2026 |
| 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 Holdings, Inc (Z-1773-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98541/
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