BEUDAMED
    FDA Recall Terminated

    InSound Medical, Inc, Lyric in-canal hearing aid.

    Recall: Z-1681-2010 · Initiated January 19, 2010

    Recall

    Recall Number
    Z-1681-2010
    Event Number
    54473
    Firm
    InSound Medical, Inc.
    FEI Number
    3003793405
    Product Code
    ESD
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    January 19, 2010
    Posted
    May 26, 2010
    Terminated
    August 2, 2011
    Address
    37500 Central Ct, Newark, CA, 94560-3454

    Description

    InSound Medical, Inc, Lyric in-canal hearing aid.

    Reason

    Manufacturing error could result in electrolyte leakage from the product's battery.

    Action

    InSound sent to its consignees a "Dear Lyric Provider" letter of explanation on 2/1/2010.

    Distribution

    Distribution only in US ( nationwide). No foreign consignees involved.

    Quantity

    2019 units