FDAFDA · Food and drugs·Recall number Z-1773-2026
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Published April 15, 2026 · Recall initiated: February 18, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- XTANT Medical Holdings, Inc
- Distributor
- US: OR
- Lot
- UDI/DI M697X0736555DL1, Lot Number 4375-01
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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