Xtant Medical Holdings, Inc: Orthosis, Spinal Pedicle Fixation
- Recalling firm
- 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
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-02-18
- Status
- Open, Classified
- Areas affected
- OR
- Distribution
- US: OR
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/45848196-a729-4e0d-abd4-43e928a6c103