BEUDAMED
    FDA Enforcement Class II Terminated

    Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018). An Implantable Middle Ear Hearing Device.

    Recall: Z-2590-2018 · Reported August 8, 2018

    Enforcement

    Recall Number
    Z-2590-2018
    Event ID
    80489
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Envoy Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 8, 2018
    Initiation Date
    June 28, 2018
    Classification Date
    August 1, 2018
    Termination Date
    November 3, 2020
    Address
    4875 White Bear Pkwy, N/A, Saint Paul, MN, 55110-3325, United States

    Description

    Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018). An Implantable Middle Ear Hearing Device.

    Reason

    Sterile Wipes packed in these four Esteem II Sound Processors had an earlier expiration date than the final pack and the Esteem II Sound Processors. The Sterile Wipes expired prior to the date labeled on the final pack.

    Code Info

    Lot Numbers: EMC0006145, EMC0006155, & EMC0006217

    Distribution

    US Distribution to states of: FL, OR

    Quantity

    4 Units