Recall Z-1773-2026 ยท MNI Orthosis, Spinal Pedicle Fixation
XTANT Medical Holdings, Inc
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
| Date | Apr 3, 2026 (initiated Feb 18, 2026) |
| Status | Open, Classified |
| Reason | 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 | 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 |
| Quantity | 2 units |
| Distribution | US: OR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152132 | X-spine Pedicle Screw System X-Spine Systems, Inc., Sep 25, 2015 |