XTANT Medical Holdings, Inc recalls XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm
- Recalling company
- XTANT Medical Holdings, Inc
- Product
- XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
- Reason
- Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Feb 18, 2026
- Reported
- Apr 15, 2026
- Distribution
- US: OR
- Status
- Ongoing
- Quantity
- 2 units
- Lot / codes
- UDI/DI M697X0736555DL1, Lot Number 4375-01
- Company location
- Belgrade, MT
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1773-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1773-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.