Recall Z-0125-2025— XTANT Medical Holdings, Inc

Name: FDA recall Z-0125-2025
Creator: U.S. Food and Drug Administration
Published: 2024-08-21

Class II · Ongoing

Class II FDA medical device recall by XTANT Medical Holdings, Inc, initiated 2024-08-21. It names one FDA 510(k) clearance: K221403. Product: Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045. Reason: 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..

Recalling firm: XTANT Medical Holdings, Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-08-21
Firm location: Belgrade, MT, United States

510(k) clearances named in this recall

1 on FDA's record

K221403 — Cortera Spinal Fixation SystemSurgalign Spine Technologies·cleared 2022-08-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.