FDA recall, , Moderate risk
XTANT Medical Xpress Pedicle Screw System
The Xpress Pedicle Screw System was mislabeled with an incorrect part number, identifying it as shorter than it is.
Summary by Recall Canary from the FDA notice
What happened
XTANT Medical Holdings, Inc., of Belgrade, Montana, recalled 2 units of its XTANT Medical Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm because the units were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is. The recall began on February 18, 2026, and was added to the FDA's Enforcement Report on April 3, 2026. The affected units were distributed in Oregon.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its lot code matches.
XTANT Medical Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
- Lot code
- 4375-01
Recall details
- Company began the recall
- Sold in
- Company
- XTANT Medical Holdings, IncBelgrade, Montana
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98541
- Recall number
- Z-1773-2026
- Quantity recalled
- 2 units
All recalls from XTANT Medical Holdings, Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
