FDAFDA · Food and drugs·Recall number Z-0892-2013
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.
Published March 13, 2013 · Recall initiated: December 18, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ad-Tech Medical Instrument Corporation
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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