XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm recall (XTANT Medical Holdings, Inc)
Medical deviceClass IIOngoing
Summary: XTANT Medical Holdings, Inc is recalling XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.. Reason: Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
What is being recalled
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Why
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US: OR
How to tell if yours is affected
UDI/DI M697X0736555DL1, Lot Number 4375-01
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1773-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 18, 2026 |
| Reported | April 15, 2026 |
| Company | XTANT Medical Holdings, Inc |
| Company location | Belgrade, MT, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 2 units |
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