Virage OCT Spinal Fixation System — Class II medical device recall Z-1019-2016
Terminated recall by Zimmer Spine, Inc., reported 2016-03-09, distributed nationwide. Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fixation System
| Recall number | Z-1019-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Spine, Inc., Minneapolis, MN, United States |
| Recall initiated | 2016-02-03 |
| Classified | 2016-02-26 |
| Reported by FDA | 2016-03-09 |
| Terminated | 2016-10-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, DE |
| Quantity | 15,753 |
Product
Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
Reason for recall
Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fixation System by providing additional guidance in the Virage OCT Surgical Technique Manual.
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-1019-2016. 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.