Z-0125-2025 Class II Ongoing
FDA device recall Z-0125-2025 was initiated by XTANT Medical Holdings, Inc on August 21, 2024 and is designated Class II. 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 sc… The recall status is ongoing. Affected quantity: 330.
Recall Details
- Product Type
- Devices
- Report Date
- October 23, 2024
- Initiation Date
- August 21, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 330
Product Description
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
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.
Distribution Pattern
US Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA.
Code Information
UDI-DI: 00810076563190, Lot: DNI