Device product
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Z-1773-2026
Product summary
- Event
- Event 98541
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-1773-2026
Official wording
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 information: UDI/DI M697X0736555DL1, Lot Number 4375-01
Distribution pattern: US: OR
Derived failure modes
-
Labeling or packaging
mislabeled