XTANT Medical Holdings, Inc: Device Recall
Recall #Z-0125-2025 · 08/21/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0125-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- XTANT Medical Holdings, Inc
- Status
- Ongoing
- Date Initiated
- 08/21/2024
- Location
- Belgrade, MT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 330
Reason for Recall
Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.
Product Description
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Distribution Pattern
US Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA.
Other Recalls by XTANT Medical Holdings, Inc
- Class II: Risk 01/03/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.