FDAHealthFebruary 18, 2026
XTANT Medical Holdings, Inc — 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.
Is this relevant to me?
- Geography
- US, OR
- Source agency
- FDA
- Category
- Health
- Published
- February 18, 2026
US: OR
What's affected?
- Product
- XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
- Lot code
- 4375-01
Additional details
UDI/DI M697X0736555DL1, Lot Number 4375-01
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2 units.
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