Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
This recall has been terminated (originally issued February 3, 2016).
- Company
- Zimmer Spine, Inc.
- Recall Initiated
- February 3, 2016
- Terminated
- October 11, 2016
- Recall Number
- Z-1019-2016
- Quantity
- 15,753
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
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.
Distribution
Distributed US (nationwide) and in the countries of Australia and Germany.
Lot / Code Info
Surgical Technique Manual L1637 Rev B (2014-06)
Root Cause
Under Investigation by firm
Action Taken
Distributors, Hospital Risk Managers and Surgeons were notified via an Urgent Medical Device Correction letter beginning 2/3/2016. The letter identified affected product, described the issue and listed their responsibilities. A Certificate of Acknowledgement form was asked to be returned to Zimmer Biomet via email to corporatequality.postmarket@zimmerbiomet.com. Questions or concerns can be directed to Customer Service at 1-866-774-6368