BEUDAMED
    FDA Recall Terminated

    Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being investigated as a device to determine possible inner ear problems.

    Recall: Z-2348-2008 · Initiated July 9, 2008

    Recall

    Recall Number
    Z-2348-2008
    Event Number
    48990
    Firm
    Acacia Engineered Products LLC
    FEI Number
    3006503914
    Product Code
    LXV
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    July 9, 2008
    Posted
    September 17, 2008
    Terminated
    February 17, 2010
    Address
    1108 Harpeth Industrial Ct, Franklin, TN, 37064-2224

    Description

    Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being investigated as a device to determine possible inner ear problems.

    Reason

    The firm distributed an unapproved medical device.

    Action

    On July 9, 2008 the firm issued a Device Recall Notification letter to its consignees by letter on July 9, 2008 by US mail. The recall notification was directed to the end users of the units requesting the return of all units. In the event of a non-responding consignee, the firm will make additional efforts to contact the individual via certified return receipt mail or other form of notification requiring a signature. Follow up direct contact through telephone will also be used. If you have any questions contact Eric Johnson at (615) 202-9370.

    Distribution

    Class II Recall - Nationwide Distribution --- including states of CA, VA, MA and TX.

    Quantity

    24