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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer, Virage OCT Spinal Fixation System

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 Class 2 Device Recall Zimmer, Virage OCT Spinal Fixation Systemsee related information
Date Initiated by FirmNovember 17, 2015
Create DateJanuary 09, 2016
Recall Status1 Terminated 3 on August 12, 2016
Recall NumberZ-0625-2016
Recall Event ID 72832
510(K)NumberK133556 
Product Classification Appliance, fixation, spinal interlaminal - Product Code KWP
ProductZimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). UDI Number 889024328952
Code Information Lots: 62968065, 62947660, 62536230, 62745662, 62773482, 62758613, 62874869
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information ContactConsumer Relations Call Center
866-774-6368
Manufacturer Reason
for Recall		Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through product testing that the staking of the set screw was out of specification and can interfere with the insertion of the occipital rod when the set screw is staked too low.
FDA Determined
Cause 2		Process control
ActionConsignees were sent a Zimmer Biomet "Urgent Medical Device Recall" letter dated November 17, 2015. One letter was addressed to Risk Manager and Surgeons and a separate letter was sent to Distributors, Sales Representatives, and Distributor Operations Mangers. The letters described the problem and the product involved in the recall. The letter described the "Risk" and the responsibilities of consignees and requested consignees to quarantine the product. Risk Managers and Surgeons were requested to complete and return the Certificate of Acknowledgment form. Distributors, Sales Representatives, and Distributor Operations Mangers were requested to complete and return the Inventory Return certification Form. For questions consignees can call the customer call center at 1-866-774-6368 between 8:00 am and 5:00 pm EST.
Quantity in Commerce372
DistributionUS: AL, AZ, CA, CO, FL, GA, ID, MI, MN, MO, NV, NJ, OK, OR, PA, SD, TN, TX, WA, WI. OUS: AUSTRALIA, GERMANY, SWITZERLAND, SWEDEN.
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
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