# FDA recall Z-2396-2019

> **Ad-Tech Medical Instrument Corporation** · Class II · device recall initiated 2019-04-16.

## 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.

## Reason for recall

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.

## Distribution

Worldwide - Nationwide distribution in the state of Illinois  and countries of Russia and United Kingdom

## Key facts

- **Recall number:** Z-2396-2019
- **Recalling firm:** Ad-Tech Medical Instrument Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-16
- **Report date:** 2019-09-04
- **Termination date:** 2022-05-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oak Creek, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2396-2019

## Citation

> AI Analytics. FDA recall Z-2396-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2396-2019. Source: US FDA. Licensed CC0.

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