Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Virage OCT Spinal Fixation System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Virage OCT Spinal Fixation Systemsee related information
Date Initiated by FirmFebruary 03, 2016
Create DateFebruary 26, 2016
Recall Status1 Terminated 3 on October 11, 2016
Recall NumberZ-1019-2016
Recall Event ID 73265
510(K)NumberK133556 
Product Classification Appliance, fixation, spinal interlaminal - Product Code KWP
ProductVirage 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/
Manufacturer		 Zimmer Spine, Inc.
7375 Bush Lake Rd
Minneapolis MN 55439-2027
For Additional Information ContactCustomer Service
866-774-6368
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
ActionDistributors, 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 Commerce15,753
DistributionDistributed US (nationwide) and in the countries of Australia and Germany.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KWP
-
-