BEUDAMED
    FDA Enforcement Class II Terminated

    TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

    Recall: Z-1608-2016 · Reported May 11, 2016

    Enforcement

    Recall Number
    Z-1608-2016
    Event ID
    73318
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Applied Medical Technology Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 11, 2016
    Initiation Date
    February 17, 2016
    Classification Date
    May 4, 2016
    Termination Date
    October 27, 2016
    Address
    8000 Katherine Blvd, Brecksville, OH, 44141-4202, United States

    Description

    TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

    Reason

    The firm received a complaint of an open pouch which breaches the sterilization validation.

    Code Info

    Part #: M0068201750; Part #: M0068201761;

    Distribution

    Product was shipped to the following states: AL, AR, AZ, CA, CT, FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, OH, PA, SC, TN,TX, UT, VA & WI. Product was also shipped to the following countries: Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland & United Kingdom.

    Quantity

    5,334 units