Class II — Ad-Tech Medical Instrument Corporation
| Recalling firm | AD-TECH MEDICAL INSTRUMENT CORP. |
|---|---|
| Registered facility | AD-TECH MEDICAL INSTRUMENT CORP. (the firm's only registered facility) |
| Classification | Class II |
| 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. |
| Product | Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes |
| 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, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, … |
| Initiated | 2019-06-18 |
| Classified | 2019-08-27 |
| Terminated | 2023-01-20 |
| Recall number | Z-2407-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ad-Tech Medical Instrument Corporation (Z-2407-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83179/
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