XTANT Medical Holdings, Inc: Medical Device Recall in 2024 - (Recall #: Z-0846-2024)

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, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.

Product Classification:

Class II

Date Initiated: November 28, 2023

Date Posted: February 7, 2024

Recall Number: Z-0846-2024

Event ID: 93738

Reason for Recall:

Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.

Status: Ongoing

Product Quantity: 6

Code Information:

UDI-DI: 00810076564005, Lot: AP23000143

Distribution Pattern:

US distribution in MI.

Voluntary or Mandated:

Voluntary: Firm initiated