Device recall
Z-1323-2015: Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a…
FDA device recall · Class II · ArthroCare Medical Corporation
Key facts
| Recall number (Z-number) | Z-1323-2015 |
|---|---|
| Recall event | 70594 |
| Product | Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for use in otorhinolaryngology (ENT) surgery. The system consists of the following components: an electrosurgical radiofrequency controller, a reusable, non-sterile… |
| Product code | GEI |
| Recalling firm | ArthroCare Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 26, 2016 |
| 510(k) numbers | K030108 |
| FEI number | 3010813691 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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