Xtant Medical Holdings, Inc.

Activity by year

Devices registered here (1)

• Sacroiliac Joint Fixation
  Product code OUR (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3040

Recalls & enforcement

• Class IIOngoing2026-03-09
  Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
• Class IIOngoing2026-02-18
  Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
• Class IIOngoing2025-01-03
  Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
• Class IIOngoing2024-08-21
  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.
• Class IIOngoing2023-11-28
  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…
• Class IITerminated2021-12-29
  The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
• Class IIITerminated2020-09-30
  Cervical Implants contain a label that incorrectly identifies the grade of titanium used.
• Class IITerminated2020-05-12
  The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld.
• Class IITerminated2019-05-03
  The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (DBM) devices which contained 5.0cc of putty, instead of 10.00cc of putty as labeled.
• Class IITerminated2018-12-19
  This recall has been initiated due to a change in packaging and sterilization method to address potential risks of compromised sterilization presented by the existing configuration.
• Class IITerminated2017-04-12
  The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium.

FDA inspections (1)

• NAI2017-08-25
  No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

• All facilities operated by Xtant Medical Holdings, Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)