Class I — Ad-Tech Medical Instrument Corporation
| Recalling firm | AD-TECH MEDICAL INSTRUMENT CORP. |
|---|---|
| Registered facility | AD-TECH MEDICAL INSTRUMENT CORP. (the firm's only registered facility) |
| Classification | Class I |
| 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. |
| 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. |
| 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. |
| Initiated | 2012-12-18 |
| Classified | 2013-03-01 |
| Terminated | 2014-10-15 |
| Recall number | Z-0892-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Ad-Tech Medical Instrument Corporation (Z-0892-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64136/
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