Recall Z-0892-2013 ยท GYC Electrode, Cortical
Ad-Tech Medical Instrument Corporation
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.
| Date | Mar 2, 2013 (initiated Dec 18, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | AD-TECH Medical Instrument Corporation sent an "Urgent Medical Device Recall" letter dated December 18, 2012 to all affected consignees. The letter described the Reason for the Voluntary Recall, Risk to Health, Actions to be taken by the Customer, Product and Distribution Information, Type of Action by Ad-Tech Medical Instrument Corporation and Other Information. Consignees were instructed to quarantine the affected product and contact the firm for a Return Material Authorization number. If the product have been further distributed consignees were advised to notify their customers of the r |
| Quantity | 144 (103 US; 41 OUS) |
| Distribution | Worldwide Distribution - USA Nationwide including the states of CA, GA, LA, MA, MD, MI, MN, NH, PA, RI, TX, UT, WI, NY IA, WI and the countries of: Australia, CANADA, ENGLAND, JAPAN, KOREA, SPAIN, FRANCE, and SWITZERLAND. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053363 | DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES Ad-Tech Medical Instrument Corp, May 30, 2006 |