FDA Enforcement
Class II
Ongoing
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Recall: Z-1773-2026
·
Reported April 15, 2026
Enforcement
- Recall Number
- Z-1773-2026
- Event ID
- 98541
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- XTANT Medical Holdings, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 15, 2026
- Initiation Date
- February 18, 2026
- Classification Date
- April 3, 2026
- Address
- 664 Cruiser Ln, Belgrade, MT, 59714-9719, United States
Description
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.
Code Info
UDI/DI M697X0736555DL1, Lot Number 4375-01
Distribution
US: OR
Quantity
2 units