XTANT Medical Holdings, Inc recalls XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm

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

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).

• FDA enforcement recordOfficial FDA database entry for Z-1773-2026
• FDA 510(k) clearance · K152132The device's official FDA premarket clearance record
• FDA device classification · MNIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3070The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find XTANT Medical Holdings, IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.