XTANT Medical Holdings, Inc: Device Recall

Recall #Z-1177-2025 · 01/03/2025

Class II: Risk

Recall Details

Recall Number: Z-1177-2025
Classification: Class II
Product Type: Device
Recalling Firm: XTANT Medical Holdings, Inc
Status: Ongoing
Date Initiated: 01/03/2025
Location: Belgrade, MT, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 14 units

Reason for Recall

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

Product Description

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))

Distribution Pattern

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

Other Recalls by XTANT Medical Holdings, Inc

Class II: Risk 08/21/2024

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.

View all recalls by XTANT Medical Holdings, Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.