Recall Z-2396-2019 ยท GZL Electrode, Depth
Ad-Tech Medical Instrument Corporation
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 th
| Date | Apr 16, 2019 |
| Status | Terminated |
| Reason | 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 | 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 | 18 |
| Distribution | Worldwide - Nationwide distribution in the state of Illinois and countries of Russia and United Kingdom |
| 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 |