BEUDAMED
    FDA Enforcement Class II Terminated

    DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electrodes for use with the VAPR Radiofrequency System are intended for resection, ablation, excision, hemostasis of blood vessels, and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and/or wrist.

    Recall: Z-0133-2013 · Reported October 31, 2012

    Enforcement

    Recall Number
    Z-0133-2013
    Event ID
    63283
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Mitek, Inc., a Johnson & Johnson Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 31, 2012
    Initiation Date
    March 12, 2012
    Classification Date
    October 24, 2012
    Termination Date
    June 5, 2015
    Address
    325 Paramount Dr, N/A, Raynham, MA, 02767, United States

    Description

    DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electrodes for use with the VAPR Radiofrequency System are intended for resection, ablation, excision, hemostasis of blood vessels, and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and/or wrist.

    Reason

    Product may have wrong large product identification label with symbols on the box indicating a S90 VAPR Electrode instead of the VAPR 3.5 hook electrode

    Code Info

    Lot Number: M1108086

    Distribution

    Nationwide distribution: USA including states of: AL, CA, CT, FL, GA, IA, ID, IL, IN, KY, MD, MI, MN, NJ, NY, OH, OR, TN, TX, UT, VA, and WA.

    Quantity

    376 units