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.

XTANT Medical Holdings, Inc 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)) | SafeCheck