Recall Z-2407-2019 ยท GZL Electrode, Depth
Ad-Tech Medical Instrument Corporation
Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes
| Date | Jun 18, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root 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 - |
| Quantity | 107,757 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes Ad-Tech Medical Instrument Corporation, Apr 12, 2017 |