- Recalling firm
- XTANT Medical Holdings, Inc
- Reason for recall
- Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
- Affected products (lot / model / serial)
- UDI/DI M697X0736555DL1, Lot Number 4375-01
- Units affected
- 2 units
- Distribution pattern
- US: OR
- Firm location
- Belgrade, MT, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1773-2026
- Recall initiated
- February 18, 2026
- FDA classification date
- April 3, 2026
- FDA report date
- April 15, 2026
- FDA event ID
- 98541
- Last updated on HTM Vibe
- July 24, 2026