FDA Medical devices recall ·
Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC… recall
- Recall number
- Z-1177-2025
- Date
- (initiated January 3, 2025)
- Company / brand
- XTANT Medical Holdings, Inc
664 Cruiser Ln, Belgrade, MT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 14 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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))
Why was it recalled?
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model X080-382819-08PC-STR: UDI-DI M697X08038281908PCSTR1, Lot Number 054961; Model Number X080-423011-08PC-STR: UDI-DI: M697X08042301108PCSTR1, Lot Number 053028
Distribution
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia.
States: Arizona California Colorado Louisiana Ohio Texas West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1177-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.