Home / Recalls / XTANT Medical Holdings, Inc / Z-0125-2025

Z-0125-2025 Class II Ongoing

Recalled by XTANT Medical Holdings, Inc — Belgrade, MT

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