Overview of recall records associated with XTANT Medical Holdings, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 4.
Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
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…
Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are…
This page summarizes recall records in which the official source identifies XTANT Medical Holdings, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
