Z-0673-2013Class I

Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm DeviceSTERILE

Name: Z-0673-2013 Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE***
Creator: Vycor Medical, Inc.
Published: 2012-08-21
License: https://open.fda.gov/license/

Vycor Medical, Inc. / initiated 2012-08-21 / Terminated / root cause: manufacturing process

FDA source

Vycor Medical, Inc. began a recall of Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS) has been designed... on 2012-08-21. FDA classified it as Class I and gives the reason as "Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0673-2013
Classification: Class I
Status: Terminated
Initiated: 2012-08-21
Posted: 2013-01-17
Terminated: 2013-05-13
Recalling firm: Vycor Medical, Inc.
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.
Product code: GZT Retractor, Self-Retaining, For Neurosurgery
Reason for recall: Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: Model # TC171105 Lot # VM83450

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0673-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0673-2013	Class I	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-16

Product code GZT

K060973Class IIVycor Surgical Access SystemsVycor Medical, LLC / cleared 2006-07-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)