FDA-Device2026-04-15Class II
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
XTANT Medical Holdings, Inc
Hazard
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
Sold states
US: OR
Affected count
2 units
Manufactured in
664 Cruiser Ln, Belgrade, MT, United States
Products
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1773-2026Original summary
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL. Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is. UDI/DI M697X0736555DL1, Lot Number 4375-01 Distribution: US: OR Affected quantity: 2 units
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