FDA DevicesClass II
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X07...
Published: April 15, 2026Recall ID: Z-1773-2026Category: devicesCountry: US
Reason for Recall / Hazard
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
Product Description & Identification
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Additional Source Details
| Field | Value |
|---|---|
| City | Belgrade |
| State | MT |
| Event id | 98541 |
| Address 1 | 664 Cruiser Ln |
| Code info | UDI/DI M697X0736555DL1, Lot Number 4375-01 |
| Postal code | 59714-9719 |
| Report date | 20260415 |
| Product type | Devices |
| Product quantity | 2 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260218 |
| Initial firm notification | Letter |
| Center classification date | 20260403 |
Overview
- Recalling FirmXTANT Medical Holdings, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionUS: OR