FDA Device recall Z-2408-2019
Skull Anchor Bolts
- FDA Device
- Class II
- terminated
- Published 2019-09-04
On 2019-09-04 the FDA classified a Class II recall of Skull Anchor Bolts by Ad Tech Medical Instrument, citing supplemental information provided with devices may indicate that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2408-2019 |
| 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
Skull Anchor Bolts
Reason
Supplemental information provided with devices may indicate 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-2408-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.