XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6 recalled over labeling errors
- Recall date
- February 18, 2026
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- XTANT Medical Holdings, Inc recalls XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
- Recall number
- Z-1773-2026
- FDA classification
- Class II
- Brand / firm
- XTANT Medical Holdings, Inc
- Sold / distributed
- US: OR
Why it was recalled
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Get recall alerts
Free email alert whenever XTANT Medical Holdings, Inc has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: XTANT Medical Holdings, Inc