Class II — 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 II |
| Status | Terminated |
| Reason | An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon encountered an issue after implanting four Ad-Tech depth electrodes. Upon initial device testing subsequent to implantation it was identified that two of the devices that were labeled as 8 contact depth electrodes (SD08R-SP05X-000) were in fact 6 contact depth electrodes (SD06R-SP05X-000) . There was no impact to the patient due to this incident. |
| Product | AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping. |
| Quantity | 18 |
| Distribution | Worldwide - Nationwide distribution in the state of Illinois and countries of Russia and United Kingdom |
| Initiated | 2019-04-16 |
| Classified | 2019-08-26 |
| Terminated | 2022-05-27 |
| Recall number | Z-2396-2019 |
| 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 II recall — Ad-Tech Medical Instrument Corporation (Z-2396-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82719/
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