Recall Z-2406-2019— Ad-Tech Medical Instrument Corporation

Name: FDA recall Z-2406-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-18

Class II · Terminated

Class II FDA medical device recall by Ad-Tech Medical Instrument Corporation, initiated 2019-06-18, terminated 2023-01-20. It names one FDA 510(k) clearance: K053363. 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..

Recalling firm: Ad-Tech Medical Instrument Corporation
Classification: Class II
Status: Terminated
Initiated: 2019-06-18
Terminated: 2023-01-20
Firm location: Oak Creek, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K053363 — DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODESAd-Tech Medical Instrument Corp·cleared 2006-05-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.