Device recall
Z-0892-2013: Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For…
FDA device recall · Class I · Ad-Tech Medical Instrument Corporation
Key facts
| Recall number (Z-number) | Z-0892-2013 |
|---|---|
| Recall event | 64136 |
| Product | Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 days) use with recording, monitoring and stimulation equipment, for the recording, monitoring and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity… |
| Product code | GYC |
| Recalling firm | Ad-Tech Medical Instrument Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 15, 2014 |
| 510(k) numbers | K053363 |
| FEI number | 2183456 |
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