CLASS II Device recall · Reported 5 Apr 2017 · FDA Enforcement Report
Altius M-ini OCT Posterior Spinal Fixation System recalled
Zimmer Biomet Spine is recalling Altius M-ini OCT Posterior Spinal Fixation System, distributed nationwide in the US. The recall was initiated on 16 Mar 2017 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-1691-2017
- FDA event ID
- 76610
- Recalling firm
- Zimmer Biomet Spine, Broomfield, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Mar 2017
- FDA classified
- 28 Mar 2017
- Reported
- 5 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Spinal Implants
Timeline
| 16 Mar 2017 | Recall initiated by company | |
| 28 Mar 2017 | Classified by FDA | +12 days |
| 5 Apr 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Zimmer Biomet is recalling the Altius M-INI OCT Posterior Spinal Fixation System because the driver is unable to mate with the screw head tulip.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; atlantoaxial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. The occipital bone screws are limited to occipital fixation only
Where it was distributed
Worldwide Distribution - US (nationwide) and Internationally to the Netherlands
Questions about this recall
Why was it recalled?
Zimmer Biomet is recalling the Altius M-INI OCT Posterior Spinal Fixation System because the driver is unable to mate with the screw head tulip.
Which lots are affected?
505951,M16562R01,505951,510710,510981,514814,533566,536398,543663,546565,546566,549528,565465,565464,567525,
Where was it sold?
Worldwide Distribution - US (nationwide) and Internationally to the Netherlands
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 Zimmer Biomet Spine
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Vitality Polyaxial Screw, 7.5mmx recalled by Zimmer Biomet Spine | Zimmer Biomet Spine | Packaging Defects | Nationwide |
| Device | CLASS II | Vitality¿ Spinal Fixation System recalled by Zimmer Biomet Spine | Zimmer Biomet Spine | Other | Nationwide |
| Device | CLASS II | Vitality¿ Spinal Fixation System recalled by Zimmer Biomet Spine | Zimmer Biomet Spine | Other | Nationwide |
| Device | CLASS II | Vitality¿ Spinal Fixation System.Spinal Intervertebral recalled | Zimmer Biomet Spine | Other | Nationwide |
| Device | CLASS II | Vitality Spinal Fixation System recalled by Zimmer Biomet Spine | Zimmer Biomet Spine | Potency & Assay | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |