Belgrade, MT, United States
XTANT Medical Holdings, Inc recalls
5 recalls recorded since 2018, most recently on 9 March 2026. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)5
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 9 March 2026
- Reason
- Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
- Distribution
- US Nationwide distribution in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1897-2026
- nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced Bone Graft Substitute
Ongoing Class II Medical devices
- Recall started
- 18 February 2026
- Reason
- Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
- Distribution
- US: OR
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1773-2026
- XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Ongoing Class II Medical devices
- Recall started
- 3 January 2025
- Reason
- Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH, TX, and WV. The country of Australia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1177-2025
- 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))
Ongoing Class II Medical devices
- Recall started
- 21 August 2024
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0125-2025
- Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Ongoing Class II Medical devices
- Recall started
- 28 November 2023
- Reason
- 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.
- Distribution
- US distribution in MI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0846-2024
- Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.