BEUDAMED
    FDA Enforcement Class II Terminated

    Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.

    Recall: Z-1310-2021 · Reported April 7, 2021

    Enforcement

    Recall Number
    Z-1310-2021
    Event ID
    87481
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arthrex, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 7, 2021
    Initiation Date
    February 24, 2021
    Classification Date
    March 26, 2021
    Termination Date
    May 2, 2023
    Address
    1370 Creekside Blvd, Naples, FL, 34108-1945, United States

    Description

    Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.

    Reason

    The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.

    Code Info

    Product Code AR-8770-02, Lot Number 032052

    Distribution

    US Nationwide distribution in the states of Ohio, Oregon, Tennessee, Texas.

    Quantity

    9 units