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All product recalls associated with XTANT Medical Holdings, Inc.
Total Recalls
4
Past Year
0
Class I (Serious)
0
Most Recent
Jan 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
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 implanted the screws may not have adequate strength or performance.
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 in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.