BEUDAMED
    FDA Enforcement Class III Terminated

    RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U

    Recall: Z-0584-2017 · Reported November 23, 2016

    Enforcement

    Recall Number
    Z-0584-2017
    Event ID
    75485
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 23, 2016
    Initiation Date
    October 11, 2016
    Classification Date
    November 16, 2016
    Termination Date
    July 25, 2017
    Address
    4100 E Milham Ave, N/A, Portage, MI, 49002-9704, United States

    Description

    RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U

    Reason

    Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen¿ Generator, because the instructions for use incorrectly contained instructions supporting the sterilization of the MultiGen¿ cables.

    Code Info

    RF MultiGen¿, 0406-900-000, Refurb RF MultiGen¿, 0406-900-000U

    Distribution

    Domestic:AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY Foreign:France, Germany, Canada, UK, Lebanon, South Africa, Chile, Hong Kong, Poland, Argentina, Spain, Greece, Italy, India, Brazil, Switzerland, Netherlands, Sweden VA/DOD:

    Quantity

    2,675