FDA Medical devices recall ·
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm… recall
- Recall number
- Z-1773-2026
- Date
- (initiated February 18, 2026)
- Company / brand
- XTANT Medical Holdings, Inc
664 Cruiser Ln, Belgrade, MT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2 units
- Hazard tags
- Mislabeling
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Why was it recalled?
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI M697X0736555DL1, Lot Number 4375-01
Distribution
US: OR
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1773-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.