XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6 — Class II medical device recall Z-1773-2026
Ongoing recall by XTANT Medical Holdings, Inc, reported 2026-04-15. Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw le
| Recall number | Z-1773-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | XTANT Medical Holdings, Inc, Belgrade, MT, United States |
| Recall initiated | 2026-02-18 |
| Classified | 2026-04-03 |
| Reported by FDA | 2026-04-15 |
| Quantity | 2 units |
| Reason classes | labeling |
| Lot numbers | 4375-01 |
| Model numbers | X073-6555-DL |
Product
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Reason for recall
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
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-1773-2026. 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.