BEUDAMED
    FDA Recall Terminated

    Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize Product Usage: Indicated to aid in tissue retraction during a surgical procedure.

    Recall: Z-1610-2016 · Initiated February 17, 2016

    Recall

    Recall Number
    Z-1610-2016
    Event Number
    73318
    Firm
    Applied Medical Technology Inc
    FEI Number
    1526012
    Product Code
    GAD
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    February 17, 2016
    Terminated
    October 27, 2016
    Address
    8000 Katherine Blvd, Brecksville, OH, 44141-4202

    Description

    Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize 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.

    Action

    AMT sent an Urgent Medical Device Recall letter dated February 17, 2016 to their customers. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Service at 440-717-4000.

    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

    2,263 Units