Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Irix-A Integrated Lumbar Fusion System Recalled by XTANT Medical Holdings, Inc Due to Certain implants in the Irix-A Lumbar Fusion System...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact XTANT Medical Holdings, Inc directly.
Affected Products
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))
Quantity: 14 units
Why Was This Recalled?
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About XTANT Medical Holdings, Inc
XTANT Medical Holdings, Inc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report