AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech… — Class II medical device recall Z-2396-2019
Terminated recall by Ad-Tech Medical Instrument Corporation, reported 2019-09-04, distributed nationwide. An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon encountered an
| Recall number | Z-2396-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ad-Tech Medical Instrument Corporation, Oak Creek, WI, United States |
| Recall initiated | 2019-04-16 |
| Classified | 2019-08-26 |
| Reported by FDA | 2019-09-04 |
| Terminated | 2022-05-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB, RU |
| Quantity | 18 |
| Reason classes | labeling |
| Lot numbers | 127219, 127357, 208140699 |
| Model numbers | SD06R-SP05X-000, SD08R-SP05X-000 |
Product
AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.
Reason for recall
An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon encountered an issue after implanting four Ad-Tech depth electrodes. Upon initial device testing subsequent to implantation it was identified that two of the devices that were labeled as 8 contact depth electrodes (SD08R-SP05X-000) were in fact 6 contact depth electrodes (SD06R-SP05X-000) . There was no impact to the patient due to this incident.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2396-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.