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 |
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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.
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510(K) Database | 510(K)s with Product Code = GZL
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