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11-24-2010, 08:10 PM #1
Advanced Bionics Announces Voluntary Recall Of The Hires 90k Cochlear Implant
Valencia, CA, November 23, 2010 – Advanced Bionics (AB), a global leader in developing advanced cochlear implant systems, announced today that it has notified the US Food & Drug Administration (FDA) that it will voluntarily recall its HiRes 90K cochlear implant device and is retrieving all unimplanted devices in distribution. This action is being taken in response to two confirmed instances where the product experienced a malfunction requiring explantation.