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U.S. Department of Health and Human Services

Class 1 Device Recall Subdural Electrode

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 Class 1 Recall
Subdural Electrode
see related information
Date Posted March 02, 2013
Recall Status1 Open
Recall Number Z-0892-2013
Recall Event ID 64136
Premarket Notification
510(K) Number
K053363 
Product Classification Electrode, Cortical - Product Code GYC
Product Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 days) use with recording, monitoring and stimulation equipment, for the recording, monitoring and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.
Code Information REF numbers (catalog numbers): EG10A-SP10N-000, EG34B-SP10X-000, EGD7A-MP12N-000, EGE4A-SP10N-000, EGE4A-SP10X-000, QG10B-SP10X-000, QG10C-SP10N-000, QG10D-SP10N-000, QG11A-SP10X-000, QG16A-SP10X-000, QG17A-SP10X-000, QG18A-SP10N-000, QG18A-SP10X-000, QG20B-SP10N-000, QG20B-SP10X-000, QG20C-SP10N-000, QG20C-SP10X-000, QG20D-SP10X-200, QG20E-SP10X-000, QG20F-SP10X-000, QG24A-SP10N-000, QG26A-SP10N-000, QG32A-SP10X-000, QG32B-SP10X-000, QG36A-SP10N-000, QG36A-SP10X-000, QG36B-SP10N-000, QG44A-SP10X-000, QG53A-SP10X-000, QG66A-SP85N-000, QG69A-SP10N-000, QG88A-SP10X-000, QG96A-SP10N-000, QG96A-SP10X-000, QG96C-SP10X-000, QG96D-SP10X-000, QGC6A-SP07N-000, QGC8A-SP10N-000, QGC8A-SP10X-000, QGC8B-SP10X-000, QGC8C-SP10X-000, QGC8D-SP10N-000, QGC8E-SP10X-000, QGC8F-SP10X-000, QS20A-SP10N-000, QS40B-SP10X-000, Lot numbers: 208140314, 208140343, 208140344, 208140353, 208140354, 208140362, 208140369, 208140374, 208140381, 208140382, 208140387, 208140390, 208140395, 208140398, 208140399, 208140414, 208140417, 208140421, 208140431, 208140443, 208140445, 208140450, 208140452, 208140453, 208140458, 019020, 208140356R, 208140357R, 208140452R, C010180001, C702201001, C703160006, C704040001, C800250002, C800350004, C801240003, C802220003, C802220005, C802220006, C805210003, C805210004, C908221002, G012111001, G012140002, G015020002, G016240001, G017250004, G017250005, G017250006, G018011001, G018011002, G018011003, G019021002, G019021003, G019150003, G112270004, G114160001, G114160002, G115080002, G115170004, G115280005, G119020004, G211220001, G608060002, G704150001, G805270001, G900211002, G903011001, G903080003, S903080004, S905280003. Recall exanded on 5/2/2013 to include additional Macro Micro Subdural Electrodes: REF numbers (catalog numbers): CG-64BPX-F436, CMMS-22PX-F478, , CG-32BPX-F412, CGIE-98BPX-F341, CGIE-82BPN-F377, CMMS-69PN-F480, CGIE-98BPN-F341, CG-9SN-F496, CG-32BPX-F426, CG-16BPX-F445, CG-16BPX-F446, CG-256PX-F425, CGIE-39BPX-F442, CG-46BPX-F465, CG-64BPX-F419, CG-32BPX-F418. Lot numbers: 20814044, 208140447, 208140463, 208140463, 208140476, 208140463, 08140463, 208140424, 208140439, G119221001,G212040002, G216040002, 218190, 208140431, 208140450, 208140432, 208140433, 208140420, 208140437, 208140450, 208140422, 208140422, 208140422, 208140422
Recalling Firm/
Manufacturer
Ad-Tech Medical Instrument Corporation
1901 William St
Racine, Wisconsin 53404-1876
Manufacturer Reason
for Recall
The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of abrading the cortical surface, and may have remaining pieces which may fracture and remain in the cortical tissue with the electrode is explanted. Recall expanded on 5/2/2013 to include additional Macro Micro Subdural Electrodes.
FDA Determined
Cause 2
DESIGN: Device Design
Action AD-TECH Medical Instrument Corporation sent an "Urgent Medical Device Recall" letter dated December 18, 2012 to all affected consignees. The letter described the Reason for the Voluntary Recall, Risk to Health, Actions to be taken by the Customer, Product and Distribution Information, Type of Action by Ad-Tech Medical Instrument Corporation and Other Information. Consignees were instructed to quarantine the affected product and contact the firm for a Return Material Authorization number. If the product have been further distributed consignees were advised to notify their customers of the recall. The letter requested consignees to return the Acknowledgement and Receipt Form. For questions contact your Ad-Tech Clinical Specialist. Expanded recall letters dated May 2, 2013 were sent out April 29, 2013. The letters were formatted as the initial ones sent on 12/18/2013.
Quantity in Commerce 144 (103 US; 41 OUS)
Distribution Worldwide Distribution - USA Nationwide including the states of CA, GA, LA, MA, MD, MI, MN, NH, PA, RI, TX, UT, WI, NY IA, WI and the countries of: Australia, CANADA, ENGLAND, JAPAN, KOREA, SPAIN, FRANCE, and SWITZERLAND.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GYC and Original Applicant = AD-TECH MEDICAL INSTRUMENT CORP.
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