Device recall
Z-0673-2013: Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE***…
FDA device recall · Class I · Vycor Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0673-2013 |
|---|---|
| Recall event | 63319 |
| 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… |
| Product code | GZT |
| Recalling firm | Vycor Medical, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 13, 2013 |
| 510(k) numbers | K060973 |
| FEI number | 3005880844 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database