FDA recall Z-1773-2026

XTANT Medical Holdings, Inc · Class II · device

Product

XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.

Reason for recall

Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.

Distribution

US: OR

Key facts

Status
Ongoing
Initiation date
2026-02-18
Report date
2026-04-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Belgrade, MT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1773-2026