Drug recall
Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 days) use with…
FDA recall event 64136 · Class I · Ad-Tech Medical Instrument Corporation
Key facts
| Event ID | 64136 |
|---|---|
| Recall numbers | Z-0892-2013 |
| Recalling firm | Ad-Tech Medical Instrument Corporation |
| Product type | Devices |
| Products | 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… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of abrading the cortical surface, and may have remaining pieces which may fracture and remain in the… |
| Initiation date | Dec 18, 2012 |
| Report date | Mar 13, 2013 |
| Termination date | Oct 15, 2014 |
| City | Racine |
| State | WI |
| Country | United States |
| FEI number | 2183456 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: