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U.S. Department of Health and Human Services

Class 2 Device Recall Depth Electrodes

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  Class 2 Device Recall Depth Electrodes see related information
Date Initiated by Firm April 16, 2019
Create Date August 26, 2019
Recall Status1 Terminated 3 on May 27, 2022
Recall Number Z-2396-2019
Recall Event ID 82719
510(K)Number K163355  
Product Classification Electrode, depth - Product Code GZL
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.
Code Information Catalog Numbers SD08R-SP05X-000 SD06R-SP05X-000  LOT NUMBERS 127219 208140699 127357 208140699  
Recalling Firm/
Manufacturer		 Ad-Tech Medical Instrument Corporation
400 W Oakview Pkwy
Oak Creek WI 53154-7213
For Additional Information Contact Mrs. Kathleen Barlow
262-634-1555
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GZL and Original Applicant = Ad-Tech Medical Instrument Corporation
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