Z-1773-2026Class II

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

Name: Z-1773-2026 XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL
Creator: XTANT Medical Holdings, Inc
Published: 2026-02-18
License: https://open.fda.gov/license/

Xtant Medical Holdings, Inc. / initiated 2026-02-18 / Open, Classified / root cause: labeling and UDI

FDA source

XTANT Medical Holdings, Inc began a recall of XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL on 2026-02-18. FDA classified it as Class II and gives the reason as "Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1773-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-18
Posted: 2026-04-03
Recalling firm: Xtant Medical Holdings, Inc.
Product: XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Product code: MNI Orthosis, Spinal Pedicle Fixation
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Xtant Medical issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignee on 2/18/2026 via FedEx. The notice explained the reason for the correction, risk to health, and requested the following: 1. Review all devices from Lot 4375-01, including devices in loose stock and devices staged in implant trays or caddies, and verify device identification using the laser-etched markings on each implant to confirm that devices are stored or staged in the appropriate location consistent with their size and configuration. 2. If any device retains non-conforming labeling, relabel the device and discard of the incorrect label and application of the corrected labeling provided by Xtant Medical. 3. No product return is required unless a device cannot be confidently verified or corrected on site; please contact Xtant Medical for further guidance in such cases. 4. Complete Correction Acknowledgement to confirm completion of the above actions. For questions, Rebecca Lennemann, SVP, Quality & Regulatory Affairs, at 1-406-924-5878, Monday through Friday, 8 a.m. to 5 p.m. (Mountain Time).
Quantity in commerce: 2 units
Distribution: US: OR
Product codes and lots: UDI/DI M697X0736555DL1, Lot Number 4375-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1773-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1773-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-15	2026-04-03

Product code MNI

K152132Class IIX-spine Pedicle Screw SystemX-Spine Systems, Inc. / cleared 2015-09-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)