XTANT Medical Holdings, Inc: Medical Device Recall in 2024 - (Recall #: Z-0125-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045

Product Classification:

Class II

Date Initiated: August 21, 2024

Date Posted: October 23, 2024

Recall Number: Z-0125-2025

Event ID: 95395

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.

Status: Ongoing

Product Quantity: 330

Code Information:

UDI-DI: 00810076563190, Lot: DNI

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated