FDA Device recall Z-2406-2019
Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes
- FDA Device
- Class II
- terminated
- Published 2019-09-04
On 2019-09-04 the FDA classified a Class II recall of Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes by Ad Tech Medical Instrument, citing supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2406-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-18 |
| Published | 2019-09-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ad Tech Medical Instrument |
| Distribution | US |
Product
Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes
Reason
Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.
Identifiers
| code_info | All catalog numbers and lot numbers distributed through May 30, 2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2406-2019%22
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