CLASS II ONGOING Device recall · Reported 23 Oct 2024 · FDA Enforcement Report
Cortera Spinal Fixation System Screw, Poly, Solid recalled
Xtant Medical Holdings is recalling Cortera Spinal Fixation System Screw, Poly, Solid, distributed nationwide in the US. The recall was initiated on 21 Aug 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0125-2025
- FDA event ID
- 95395
- Recalling firm
- Xtant Medical Holdings, Belgrade, MT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Aug 2024
- FDA classified
- 17 Oct 2024
- Reported
- 23 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Spinal Implants
Timeline
| 21 Aug 2024 | Recall initiated by company | |
| 17 Oct 2024 | Classified by FDA | +57 days |
| 23 Oct 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Where it was distributed
US Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA.
Nationwide CaliforniaFloridaIllinoisMassachusettsMichiganMissouriOhioPennsylvaniaTexasVirginiaWisconsin
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI-DI: 00810076563190, Lot: DNI
Where was it sold?
US Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Xtant Medical Holdings
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus recalled | Xtant Medical Holdings | Labeling Errors | Nationwide |
| Device | CLASS II | Xtant Medical Xpress Pedicle Screw System Dual Lead recalled | Xtant Medical Holdings | Labeling Errors | OR |
| Device | CLASS II | Irix-A Integrated Lumbar Fusion System recalled | Xtant Medical Holdings | Other | Nationwide |
| Device | CLASS II | Cortera Spinal Fixation System recalled by XTANT Medical Holdings | Xtant Medical Holdings | Other | MI |
Other Spinal Implants recalls
All 1,159| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Extended Polyaxial Head, Attached Gimbal recalled | Seaspine Orthopedics | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Anterior Spine Pack recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |