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Z-1773-2026Class II

XTANT Medical Holdings, Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

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
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

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. 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. Open the enforcement explorer →