Device recall
Z-1719-2014: MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The…
FDA device recall · Class II · ConMed Corporation
Key facts
| Recall number (Z-number) | Z-1719-2014 |
|---|---|
| Recall event | 68193 |
| Product | MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator. |
| Product code | GEI |
| Recalling firm | ConMed Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 11, 2017 |
| 510(k) numbers | K120476 |
| FEI number | 3001451571 |
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