FDA recall Z-0125-2025

XTANT Medical Holdings, Inc · Class II · device

Product

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

US Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA.

Key facts

Status
Ongoing
Initiation date
2024-08-21
Report date
2024-10-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Belgrade, MT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0125-2025