Date Initiated by Firm | August 21, 2012 |
Date Posted | 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
|