BEUDAMED
    FDA Recall Terminated

    Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.

    Recall: Z-2156-2014 · Initiated June 24, 2014

    Recall

    Recall Number
    Z-2156-2014
    Event Number
    68807
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    LFL
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    June 24, 2014
    Posted
    August 7, 2014
    Terminated
    October 27, 2015
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704

    Description

    Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.

    Reason

    The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. Lack of irrigation can potentially lead to excessive heat at the tip.

    Action

    The firm sent Medical Device Upgrade Notification letters dated July 11, 2014 to their customers.

    Distribution

    Nationwide Distribution-including DC and the states of AK, AL, AR, AZ, CA, CO, CT, 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, RI, SC, TN, TX, UT, VA, VT, WA, WI & WV.

    Quantity

    2,460 units