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XTANT Medical Holdings, Inc recalls Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) an
Recalled February 26, 2025 · FDA recall Z-1177-2025 · XTANT Medical Holdings
Hazard
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date. · FDA Class II
Units
14 units
Sold at
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia.
Description
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
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))
Manufacturer(s)
XTANT Medical Holdings, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →