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XTANT Medical Holdings, Inc FDA Recalls
5 recalls on file across devices, 0 of them Class I and 5 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D AdvaClass IIMar 9, 2026Products were incorrectly labeled with a 5-year shelf life. |
| XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.Class IIFeb 18, 2026Units from one lot were mislabeled with an incorrect part nu |
| Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) anClass IIJan 3, 2025Certain implants in the Irix-A Lumbar Fusion System were dis |
| Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045Class IIAug 21, 2024Spinal fixation system implant screws marked "DNI" are not i |
| Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.Class IINov 28, 2023Spinal fixation screws labeled as 8.5 mm diameter, 50 mm len |