BEUDAMED
    FDA Enforcement Class II Ongoing

    FG 57 100057X (100057X)

    Recall: Z-0465-2021 · Reported November 25, 2020

    Enforcement

    Recall Number
    Z-0465-2021
    Event ID
    86694
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Coltene Whaledent Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 25, 2020
    Initiation Date
    October 20, 2020
    Classification Date
    November 17, 2020
    Address
    235 Ascot Pkwy, N/A, Cuyahoga Falls, OH, 44223-3701, United States

    Description

    FG 57 100057X (100057X)

    Reason

    The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.

    Code Info

    J79552

    Distribution

    Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.

    Quantity

    556