# FDA recall Z-2406-2019

> **Ad-Tech Medical Instrument Corporation** · Class II · device recall initiated 2019-06-18.

## Product

Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes

## Reason for recall

Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.

## Distribution

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.      Worldwide distribution to Albania, Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Malaysia, Mexico, Netherlands, Nicaragua, Pakistan, Panama, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Syria, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam.

## Key facts

- **Recall number:** Z-2406-2019
- **Recalling firm:** Ad-Tech Medical Instrument Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-18
- **Report date:** 2019-09-04
- **Termination date:** 2023-01-20

- **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-2406-2019

## Citation

> AI Analytics. FDA recall Z-2406-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2406-2019. Source: US FDA. Licensed CC0.

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