FDA-Device2025-02-26Class II
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
Hazard
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
Sold states
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia.
Affected count
14 units
Manufactured in
664 Cruiser Ln, N/A, Belgrade, MT, United States
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))
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1177-2025Don't want to check this manually?
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