Device recall
Z-0008-2013: Sterile, single-use, disposable electrosurgical electrode holder. It connects…
FDA device recall · Class III · Gynex Corporation
Key facts
| Recall number (Z-number) | Z-0008-2013 |
|---|---|
| Recall event | 63253 |
| Product | Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***" Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece) It… |
| Product code | HGI |
| Recalling firm | Gynex Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 22, 2012 |
| 510(k) numbers | K0404780 |
| FEI number | 3001238683 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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