FDA Device recall Z-1019-2016
Virage OCT Spinal Fixation System
- FDA Device
- Class II
- terminated
- Published 2016-03-09
On 2016-03-09 the FDA classified a Class II recall of Virage OCT Spinal Fixation System by Zimmer Spine, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1019-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-03 |
| Published | 2016-03-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Spine |
| Distribution | US |
Product
Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
Reason
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.
Identifiers
| code_info | Surgical Technique Manual L1637 Rev B (2014-06) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1019-2016%22
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