BEUDAMED
    FDA Enforcement Class II Terminated

    Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part Number): a) 3 Hole (003-D-01001); b) 4 Hole (003-D-02001); c) 6 Hole (003-D-03001)

    Recall: Z-2132-2018 · Reported June 13, 2018

    Enforcement

    Recall Number
    Z-2132-2018
    Event ID
    79819
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthofix, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 13, 2018
    Initiation Date
    April 6, 2018
    Classification Date
    June 7, 2018
    Termination Date
    June 30, 2021
    Address
    3451 Plano Pkwy, N/A, Lewisville, TX, 75056-9453, United States

    Description

    Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part Number): a) 3 Hole (003-D-01001); b) 4 Hole (003-D-02001); c) 6 Hole (003-D-03001)

    Reason

    Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.

    Code Info

    (UDI)/Lot: a) (18056099647809) B1096736; b) (18056099647816) B1096738; c) (18056099647823) B1096739

    Distribution

    U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,

    Quantity

    38