Virage OCT Spinal Fixation System. Intended to promote recall
Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
Why was Virage OCT Spinal Fixation System. Intended to promote recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Surgical Technique Manual L1637 Rev B (2014-06)
- Product
- Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
- Recalling firm
- Zimmer Spine, Inc.
- Quantity
- 15,753
- Distribution
- Distributed US (nationwide) and in the countries of Australia and Germany.
- Recall date
- March 9, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)