XTANT Medical Holdings, Inc
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for XTANT Medical Holdings, Inc and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-04-15FDA-DeviceClass IIXTANT 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.
- 2025-02-26FDA-DeviceClass IIIrix-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))
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
- 2024-10-23FDA-DeviceClass IICortera 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 adequate strength or performance.
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