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XTANT Medical Holdings Recalls
5 recalls on record · February 7, 2024 to April 29, 2026 · Medical Devices
Recalls by year
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
April 29, 2026Medical DevicesFDA
XTANT Medical Holdings, Inc recalls nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Adva
Hazard: Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
April 15, 2026Medical DevicesFDA
XTANT Medical Holdings, Inc recalls XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Hazard: Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
February 26, 2025Medical DevicesFDA
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
Hazard: Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
October 23, 2024Medical DevicesFDA
XTANT Medical Holdings, Inc recalls Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Hazard: 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.
February 7, 2024Medical DevicesFDA
XTANT Medical Holdings, Inc recalls Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Hazard: 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.