FDA Device recall Z-1773-2026
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL
- FDA Device
- Class II
- ongoing
- Published 2026-04-15
On 2026-04-15 the FDA classified a Class II recall of XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL by Xtant Medical Holdings, citing units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1773-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-18 |
| Published | 2026-04-15 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Xtant Medical Holdings |
| Distribution | OR |
Product
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Reason
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
Identifiers
| code_info | UDI/DI M697X0736555DL1, Lot Number 4375-01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1773-2026%22
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