Z-2396-2019Class II

AD-TECH Spencer Probe Depth Electrode

Name: Z-2396-2019 AD-TECH Spencer Probe Depth Electrode
Creator: Ad-Tech Medical Instrument Corporation
Published: 2019-04-16
License: https://open.fda.gov/license/

AD-Tech Medical Instrument Corp. / initiated 2019-04-16 / Terminated / root cause: labeling and UDI

FDA source

Ad-Tech Medical Instrument Corporation began a recall of AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth... on 2019-04-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2396-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-16
Posted: 2019-08-26
Terminated: 2022-05-27
Recalling firm: AD-Tech Medical Instrument Corp.
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.
Product code: GZL Electrode, Depth
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Via a MEDICAL DEVICVE RECALL letter dated, April 17, 2019, Ad-Tech advised their consignees of the mix-up, requested that they check their stock, returned the MEDICAL DEVICE RECALL RETURN RESPONSE, and return the subject devices. Distributors were requested to conduct a sub-recall to their customers.
Quantity in commerce: 18
Distribution: Worldwide - Nationwide distribution in the state of Illinois and countries of Russia and United Kingdom
Product codes and lots: Catalog Numbers SD08R-SP05X-000 SD06R-SP05X-000 LOT NUMBERS 127219 208140699 127357 208140699

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2396-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2396-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-26

Product code GZL

K163355Class IIDepth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth ElectrodesAd-Tech Medical Instrument Corporation / cleared 2017-04-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)