XTANT Medical Holdings, Inc recalls Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045

Recall date

August 21, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0125-2025

FDA classification

Class II

Brand / firm

XTANT Medical Holdings, Inc

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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