BEUDAMED
    FDA Enforcement Class II Terminated

    The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are designed to be used with the SurgiCounter and are part of the SurgiCount Safety-Sponge System. The SurgiCount Safety-Sponge System is indicated for use in counting and recording the number of Safety-Sponge surgical sponges, laparotomy sponges, and towels used during surgical procedures.

    Recall: Z-0986-2015 · Reported January 21, 2015

    Enforcement

    Recall Number
    Z-0986-2015
    Event ID
    70093
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 21, 2015
    Initiation Date
    June 16, 2013
    Classification Date
    January 15, 2015
    Termination Date
    August 20, 2015
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704, United States

    Description

    The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are designed to be used with the SurgiCounter and are part of the SurgiCount Safety-Sponge System. The SurgiCount Safety-Sponge System is indicated for use in counting and recording the number of Safety-Sponge surgical sponges, laparotomy sponges, and towels used during surgical procedures.

    Reason

    Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure.

    Code Info

    Part number: SC-0014 All lots at time of notice 6/16/2013

    Distribution

    US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.

    Quantity

    3625