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U.S. Department of Health and Human Services

Class 1 Device Recall Vycor Medical ViewSite Brain Access System

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  Class 1 Device Recall Vycor Medical ViewSite Brain Access System see related information
Date Initiated by Firm August 21, 2012
Date Posting Updated January 17, 2013
Recall Status1 Terminated 3 on May 13, 2013
Recall Number Z-0673-2013
Recall Event ID 63319
510(K)Number K060973  
Product Classification Retractor, self-retaining, for neurosurgery - Product Code GZT
Product Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE***

Product Usage:
The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.
Code Information Model # TC171105, Lot # VM83450
Recalling Firm/
Manufacturer
Vycor Medical, Inc.
6401 Congress Ave Ste 140
Boca Raton FL 33487-2841
For Additional Information Contact
561-558-2020
Manufacturer Reason
for Recall
Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.
FDA Determined
Cause 2
Equipment maintenance
Action Vycor Medical, Inc. notified all customers of the product recall by telephone and follow-up letter. Customers were instructed to quarantine affected products and hold the shipment(s) in quarantine unti further notice. The units will be replaced with inspected and passed units. All distributors were instructed to notify their customers of the recall and ask to have them return their stock. For question call 561-558-2020.
Quantity in Commerce 3000 devices
Distribution Worldwide Distribution - USA (Nationwide) in the states of TX, IL, NJ, FL, OH, PA and (International) in the country of Japan.
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 = GZT and Original Applicant = VYCOR MEDICAL LLC
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