Recall Z-1019-2016 ยท KWP Appliance, Fixation, Spinal Interlaminal
Zimmer Spine, Inc.
Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
| Date | Feb 3, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 15,753 |
| Distribution | Distributed US (nationwide) and in the countries of Australia and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133556 | VIRAGE OCT SPINAL FIXATION SYSTEM Zimmer Spine, Inc., Jun 2, 2014 |