XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | February 18, 2026 |
| Reported | April 15, 2026 |
| Recalling firm | XTANT Medical Holdings, Inc |
| Country / region | United States MT |
Hazard
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
Affected products
- XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
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