XTANT MEDICAL Xpress Pedicle Screw System
XTANT MEDICAL is recalling Xpress Pedicle Screw System 6.5 x 50 mm (X073-6555-DL) due to mislabeling identifying incorrect screw length.
Contact XTANT Medical Holdings, Inc. immediately to determine if your facility received affected units from the recalled lot. Do not use affected screws until the correct labeling is verified. Return the mislabeled devices to the manufacturer.
Recall at a glance
- Quantity recalled
- 2 units
Why it was recalled
XTANT MEDICAL is recalling Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm (Part Number X073-6555-DL) from one lot due to mislabeling with an incorrect part number that identifies the device as a shorter screw length than it actually is. This mislabeling could lead to incorrect surgical placement and patient harm.
Is mine affected?
This recall covers the product below. If you have it, yours is affected.
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Where it was sold
Distributed in Oregon.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from XTANT Medical Holdings, Inc
Editorial summary by Recall Canary · summary updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification