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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 22 of 22 Results
Recall Date from: 01/01/2003 Recall Date to: 09/01/2015 Firm: Advanced Bionics
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HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear System is a... 2 10/22/2012 Advanced Bionics Corporation
OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The Precision Spinal Cord... 2 04/19/2012 Advanced Bionics Corporation
Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI-1400-01 ... 2 12/21/2010 Advanced Bionics Corporation
Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI-1400-02H ... 2 12/21/2010 Advanced Bionics Corporation
Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-1400-01 and CI-1400-02H, Implant Magnet Case.... 2 09/11/2009 Advanced Bionics LLC
HR90K Platinum Series Headpiece Model Number AB-7300-001 ADVANCED BIONICS LLC 12740 San Fernando Rd.... 2 02/03/2009 Advanced Bionics LLC
Platinum Series Headpiece Model Number AB-7300. The headpiece is used in conjunction with speech pr... 2 02/03/2009 Advanced Bionics LLC
S-Series Short Range Headpiece Model Number MMT-5300-00 (beige) and MMT-5300-10 (brown) ADVANCED BI... 2 02/03/2009 Advanced Bionics LLC
S-Series Long Range Headpiece Model Number AB-5301-00 (beige) and AB-5301-10 (brown) ADVANCED BIONI... 2 02/03/2009 Advanced Bionics LLC
Precision Charger 1.0 (Model Number SC-5300) for the Precision Spinal Cord Stimulator System labeled... 2 10/31/2008 Advanced Bionics Corp
Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number: SC-1110 with firmware vers... 2 02/27/2008 Advanced Bionics Corp
Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number SC-1100 with firmware versi... 2 02/27/2008 Advanced Bionics Corp
Precision Implantable Pulse Generator (IPG), Model Number SC-110 2 10/12/2007 Advanced Bionics Corp
The Precision Implantable Pulse Generator, Model Number SC-1110 3 03/31/2007 Advanced Bionics Corp
Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Mode... 2 01/10/2007 Advanced Bionics Corporation
The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with feedthrus from a ... 2 04/11/2006 Advanced Bionics Corporation
The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with feedthrus from a ... 2 04/11/2006 Advanced Bionics Corporation
Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System 3 01/15/2005 Advanced Bionics Corporation
Advanced Bionics implantable cochlear stimulator CLARION CII Models AB-5100H-11A AB-5100h-12A 2 10/23/2004 Advanced Bionics
Advanced Bionics implantable cochlear stimulator CLARION 1.2 Models AB-5100L AB-5100R AB-510... 2 10/23/2004 Advanced Bionics
Advanced Bionics implantable cochlear stimulator HiRes 90, Models CI-1400-01 CI-1400-02 2 10/23/2004 Advanced Bionics
Auria PowerPak, Model CI-7400-xxx where xxx denotes color/cable length options. 2 08/10/2004 Advanced Bionics Corporation
 
 
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