XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Recall
- Recall Number
- Z-1773-2026
- Event Number
- 98541
- Firm
- XTANT Medical Holdings, Inc
- FEI Number
- 3005031160
- Product Code
- MNI
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- February 18, 2026
- Posted
- April 3, 2026
- Address
- 664 Cruiser Ln, Belgrade, MT, 59714-9719
Description
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
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).
US: OR
2 units