Class 2 Device Recall Subdural Electrodes

• Date Initiated by Firm: June 18, 2019
• Create Date: August 28, 2019
• Recall Status: Terminated on January 20, 2023
• Recall Number: Z-2406-2019
• Recall Event ID: 83179
• 510(K)Number: K053363
• Product Classification: Electrode, cortical - Product Code GYC
• Product: Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes
• Code Information: All catalog numbers and lot numbers distributed through May 30, 2019
• Recalling Firm/ Manufacturer: Ad-Tech Medical Instrument Corporation; 400 W Oakview Pkwy; Oak Creek WI 53154-7213
• For Additional Information Contact: Kathleen Barlow; 262-634-1555
• Manufacturer 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.
• FDA Determined Cause: Employee error
• Action: Ad-Tech Medical Instrument Corporation notified customers on about 06/18/2019, via "MEDICAL DEVICE RECALL" letter. The letter notified customers that the recall included supplemental information and not the actual physical device. Supplemental information includes: 1. Catalog - MKTG-3006 Product Catalog; 2. Attachment/Files: - Subdural MRI Certification, - Subdural  MRI Testing  Scheinder, - Subdural  RF Heating  Kanal, - Depth Electrode MRI Certification, - Depth  MRI Testing  Scheinder, - Depth  RF Heating  Kanal; 3. Journal Articles: Carmichael_NI_2010 - Feasibility of simultaneous intracranial EEG-fMRI in humans: A safety study, Carmichael_NI_2012  Simultaneous EEG-fMRI in humans: Protocol considerations and data quality, Vulliemoz_NI_2011  Simultaneous intracranial EEG and fMRI of interictal epileptic discharges in humans. Actions to be taken by the customer included to immediately examine records for any documentation subject to the recall for affected devices, and if any of the affected documentation has been further distributed, to identify those customers/personnel and immediately notify them of the recall. A copy of the recall notification letter can be included in that notification. Customers were also requested to complete the provided response form to acknowledge understanding that the devices are not approved for use as described in the recalled supplemental information. The response form also requested that customers acknowledge that the supplemental information has been properly destroyed and/or dispose of. The response form should be returned to the Ad-Tech Regulatory Team at FAX: 262-634-5668, Telephone: 262-634-1555, Email: Regulatory@adtechmedical.com. Questions or issues can also be directed to this team at the above contacts Monday - Friday 7:00 AM to 5:00 PM, Central Time.
• Quantity in Commerce: 187,666 devices with possible affected supplemetal information
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GYC