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U.S. Department of Health and Human Services

Class 2 Device Recall Virage OCT Spinal Fixation System

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  Class 2 Device Recall Virage OCT Spinal Fixation System see related information
Date Initiated by Firm February 03, 2016
Create Date February 26, 2016
Recall Status1 Terminated 3 on October 11, 2016
Recall Number Z-1019-2016
Recall Event ID 73265
510(K)Number K133556  
Product Classification Appliance, fixation, spinal interlaminal - Product Code KWP
Product Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
Code Information Surgical Technique Manual L1637 Rev B (2014-06)
Recalling Firm/
Zimmer Spine, Inc.
7375 Bush Lake Rd
Minneapolis MN 55439-2027
For Additional Information Contact Customer Service
Manufacturer 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.
FDA Determined
Cause 2
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 in Commerce 15,753
Distribution Distributed US (nationwide) and in the countries of Australia and Germany.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWP and Original Applicant = ZIMMER SPINE, INC.