Device product
Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
Z-1019-2016
Product summary
- Event
- Event 73265
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15,753
- Official record key
device-enforcement:Z-1019-2016
Official wording
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.
Code information: Surgical Technique Manual L1637 Rev B (2014-06)
Distribution pattern: Distributed US (nationwide) and in the countries of Australia and Germany.
Derived failure modes
-
Unknown
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.