BEUDAMED
    FDA Enforcement Class II Ongoing

    3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: Actuation Driver, 6.2mm Reamer, 3.2mm Reamer, 2 mm Drill, Spade Tip Guide Wire, and 1.6mm x 12 K-Wire.

    Recall: Z-0442-2019 · Reported November 21, 2018

    Enforcement

    Recall Number
    Z-0442-2019
    Event ID
    81119
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Arthrex, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    November 21, 2018
    Initiation Date
    September 13, 2018
    Classification Date
    November 9, 2018
    Address
    1370 Creekside Blvd, Naples, FL, 34108-1945, United States

    Description

    3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: Actuation Driver, 6.2mm Reamer, 3.2mm Reamer, 2 mm Drill, Spade Tip Guide Wire, and 1.6mm x 12 K-Wire.

    Reason

    There is potential to break during use.

    Code Info

    Part #ST6100, Lot/Serial #'s: A251217-04, A011217-01, A011217-03, A091017-05, A101017-01, A111017-01, A121017-01, A121017-02, A131017-01, A140917-01, A161017-01, A171017-01, A181017-07, A221117-01, A271117-01, A281117-02, A291117-01, A291117-03, A301117-01, A281117-01.

    Distribution

    Distributed throughout the U.S. to the following states: NC, CA, NJ, CO, NV, UT, LA, KY, OH, AZ, MO, MN, TN, NY, WI, MA, PA, TX, IL, PA, AR, FL, IA, MI, AL, SD, OR, WA, MD, KS, and GA.

    Quantity

    832