FDA-Device2026-04-15Class IIMISBRANDING
XTANT Medical Xpress Pedicle Screw System mislabeled with incorrect length
LABEL MIX UPOR
Check XTANT Medical pedicle screws for correct labeling
Two units of XTANT Medical Xpress Pedicle Screw System (Part Number X073-6555-DL, Lot 4375-01) were mislabeled with an incorrect part number. The label indicates a shorter screw length than what the device actually is, which could cause confusion during surgical use.
- If you have this product (Lot 4375-01), verify the physical screw length matches the actual part number X073-6555-DL before use
- Contact XTANT Medical or your supplier if you have units from this lot
- Do not use if there is any discrepancy between the label and the actual device
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-1773-2026Don't want to check this manually?
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