Altius M-INI OCT Posterior Spinal Fixation System — Class II medical device recall Z-1691-2017
Terminated recall by Zimmer Biomet Spine, Inc, reported 2017-04-05, distributed nationwide. Zimmer Biomet is recalling the Altius M-INI OCT Posterior Spinal Fixation System because the driver is unable
| Recall number | Z-1691-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet Spine, Inc, Broomfield, CO, United States |
| Recall initiated | 2017-03-16 |
| Classified | 2017-03-28 |
| Reported by FDA | 2017-04-05 |
| Terminated | 2018-07-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | NL |
| Quantity | 141 |
| Model numbers | 1200-9216 |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1691-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.