Recall Z-0673-2013 ยท GZT Retractor, Self-Retaining, For Neurosurgery
Vycor Medical, Inc.
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
| Date | Jan 17, 2013 (initiated Aug 21, 2012) |
| Status | Terminated |
| Reason | Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device. |
| Root cause | 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 | 3000 devices |
| Distribution | Worldwide Distribution - USA (Nationwide) in the states of TX, IL, NJ, FL, OH, PA and (International) in the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060973 | VYCOR SURGICAL ACCESS SYSTEMS Vycor Medical, LLC, Jul 26, 2006 |