← FDA ENFORCEMENT
Z-1773-2026Class II

XTANT Medical Holdings, Inc

Recalling firm
XTANT Medical Holdings, Inc
Product type
Device
Status
Ongoing
Report date
2026-04-15
Distribution
US: OR
Firm state
MT
Product quantity
2 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
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.

Product description

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

Code / lot info

UDI/DI M697X0736555DL1, Lot Number 4375-01

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.