Recall Z-1773-2026— XTANT Medical Holdings, Inc

Name: FDA recall Z-1773-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-18

Class II · Ongoing

Class II FDA medical device recall by XTANT Medical Holdings, Inc, initiated 2026-02-18. It names one FDA 510(k) clearance: K152132. Product: XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.. Reason: Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is..

Recalling firm: XTANT Medical Holdings, Inc
Classification: Class II
Status: Ongoing
Initiated: 2026-02-18
Firm location: Belgrade, MT, United States

510(k) clearances named in this recall

1 on FDA's record

K152132 — X-spine Pedicle Screw SystemX-Spine Systems, Inc.·cleared 2015-09-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.