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XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x… recallZ-1773-2026 · XTANT Medical Holdings, Inc · initiated Feb 18, 2026

Class II Open, Classified All recalls posted in April 2026

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from XTANT Medical Holdings, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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).

Recall details

Recall number
Z-1773-2026
Recall class
Class II
Status
Open, Classified
Initiated by the company
Feb 18, 2026
Posted by the FDA
Apr 3, 2026
Recalling firm
XTANT Medical Holdings, Inc
Quantity
2 units
Product code
MNI
FDA submissions
K152132
Distribution
US: OR

Product description

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

Code information (models, lots, serial numbers)

UDI/DI M697X0736555DL1, Lot Number 4375-01

Other devices under the same FDA submission

8 devices cleared under K152132 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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