Recall Z-0892-2013— Ad-Tech Medical Instrument Corporation

Name: FDA recall Z-0892-2013
Creator: U.S. Food and Drug Administration
Published: 2012-12-18

Class I · Terminated

Class I FDA medical device recall by Ad-Tech Medical Instrument Corporation, initiated 2012-12-18, terminated 2014-10-15. It names one FDA 510(k) clearance: K053363. 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 supports definition of the location of epileptogenic foci and brain mapping.. Reason: 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 cortical tissue with the electrode is explanted. Recall expanded on 5/2/2013 to include additional Macro Micro Subdural Electrodes..

Recalling firm: Ad-Tech Medical Instrument Corporation
Classification: Class I
Status: Terminated
Initiated: 2012-12-18
Terminated: 2014-10-15
Firm location: Racine, 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

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 supports definition of the location of epileptogenic foci and brain mapping.

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 cortical tissue with the electrode is explanted. Recall expanded on 5/2/2013 to include additional Macro Micro Subdural Electrodes.

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