Ad-Tech Medical Instrument Corporation: Medical Device Recall in 2019 - (Recall #: Z-2396-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: April 16, 2019

Date Posted: September 4, 2019

Recall Number: Z-2396-2019

Event ID: 82719

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.

Status: Terminated

Product Quantity: 18

Code Information:

Catalog Numbers SD08R-SP05X-000 SD06R-SP05X-000 LOT NUMBERS 127219 208140699 127357 208140699

Distribution Pattern:

Worldwide - Nationwide distribution in the state of Illinois and countries of Russia and United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated