Class 2 Device Recall XTANT MEDICAL Xpress Pedicle Screw System

• Date Initiated by Firm: February 18, 2026
• Date Posted: April 03, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1773-2026
• Recall Event ID: 98541
• 510(K)Number: K152132
• Product Classification: Orthosis, spinal pedicle fixation - Product Code MNI
• Product: XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
• Code Information: UDI/DI M697X0736555DL1, Lot Number 4375-01
• FEI Number: 3005031160
• Recalling Firm/ Manufacturer: XTANT Medical Holdings, Inc; 664 Cruiser Ln; Belgrade MT 59714-9719
• For Additional Information Contact: Michele Dolan; 406-813-4145
• Manufacturer 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.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MNI