Ad-Tech Medical Instrument Corporation: Medical Device Recall in 2019 - (Recall #: Z-2406-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 18, 2019

Date Posted: September 4, 2019

Recall Number: Z-2406-2019

Event ID: 83179

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.

Status: Terminated

Product Quantity: 187,666 devices with possible affected supplemetal information

Code Information:

All catalog numbers and lot numbers distributed through May 30, 2019

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated