Official recall notice
FDA DeviceClass IINotable
FDA Recall: XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
- Recall date
- 2026-04-15
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
Recommended action
What to do
2 units
Product description
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.