Class II

Medical Device Recall: 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))

XTANT Medical Holdings, Inc · January 3, 2025

Reason for Recall

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

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

14 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1177-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.