BEUDAMED
    FDA Enforcement Class II Terminated

    Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone.

    Recall: Z-1883-2018 · Reported May 23, 2018

    Enforcement

    Recall Number
    Z-1883-2018
    Event ID
    79994
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Coltene Whaledent Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    May 23, 2018
    Initiation Date
    April 13, 2018
    Classification Date
    May 15, 2018
    Termination Date
    April 8, 2019
    Address
    235 Ascot Pkwy, Cuyahoga Falls, OH, 44223-3701, United States

    Description

    Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone.

    Reason

    The products are labeled with an incorrect product number.

    Code Info

    Batch I37640

    Distribution

    The products were distributed to the following US states: NY. The products were distributed to the following foreign countries: Canada

    Quantity

    11