BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0584-2017 · Initiated October 11, 2016

    Recall

    Recall Number
    Z-0584-2017
    Event Number
    75485
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    GXD
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    October 11, 2016
    Posted
    November 16, 2016
    Terminated
    July 25, 2017
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704

    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.

    Action

    Stryker Instruments initiated a voluntary recall of the RF MultiGen, and Refurb RF MultiGen because the instructions for use contained incorrect instructions on sterilizing the device. Stryker distributed customer notices via certified mail on 10/11/2016. Customer's were instructed to do the following: Immediately review this recall notification. 2. Enclosed was a revised version of the IVS Care Instructions. Please distribute the revised version to the appropriate person or department. 3. Remove and discard any previously distributed IVS Care Instructions or Instructions for Use. 4. Please complete, sign, and return the enclosed Business Reply Form (BRF) acknowledging your receipt and understanding of this notification. 5. Fax the completed BRF to Stryker Instruments Regulatory Department, 866-521-2762, or scan and email a copy to [email protected]. Customers with questions can contact: 269 323 7700 .

    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