XTANT Medical Holdings recalls
5 official recalls and safety alerts involving XTANT Medical Holdings since 2024-02, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with XTANT Medical Holdings or the relevant agency.
- 2026-04-29
USXTANT Medical Holdings, Inc recalls nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft…
Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
FDA · DeviceXTANT Medical Holdings, IncUS Nationwide distribution in the states and territories of CA, CT, DC, KS,…Official notice →- 2026-04-15
- US
XTANT Medical Holdings, Inc recalls XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.
Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
- 2025-02-26
- US
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)) and Model…
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
FDA · DeviceXTANT Medical Holdings, IncWorldwide - US Nationwide distribution in the states of AZ, CA, CO, LA, OH,…Official notice → - 2024-10-23
- US
XTANT Medical Holdings, Inc recalls Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
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…
FDA · DeviceXTANT Medical Holdings, IncUS Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO,…Official notice → - 2024-02-07
- US
XTANT Medical Holdings, Inc recalls Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
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…