XTANT Medical Holdings, Inc recalls Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) a…

Recall date

January 3, 2025

Source

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

Recall number

Z-1177-2025

FDA classification

Class II

Brand / firm

XTANT Medical Holdings, Inc

Sold / distributed

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia.

Why it was recalled

Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.

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

What was recalled

Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8¿, 19mm, PC, (STERILE))