BEUDAMED
    FDA Enforcement Class II Terminated

    1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser Lithotripsy fiber and EndoStat fiber accessory. The Fiber Cleaver does not come in direct contact with the patient.

    Recall: Z-2171-2015 · Reported July 29, 2015

    Enforcement

    Recall Number
    Z-2171-2015
    Event ID
    71534
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    American Medical Systems Innovation Center - Silicon Valley
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 29, 2015
    Initiation Date
    May 28, 2015
    Classification Date
    July 21, 2015
    Termination Date
    January 19, 2016
    Address
    3070 Orchard Dr, N/A, San Jose, CA, 95134-2011, United States

    Description

    1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser Lithotripsy fiber and EndoStat fiber accessory. The Fiber Cleaver does not come in direct contact with the patient.

    Reason

    validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products

    Code Info

    Model 80-10007-001; All product manufactured from April 8, 2012 to April 8, 2015

    Distribution

    Worldwide Distribution - US Nationwide in the countries of: Argentina France Morocco, South Africa, Australia, Germany, Netherlands, Spain, Austria, Greece, New Zealand, Sri Lanka, Belgium, Guatemala, Norway, Switzerland, Bolivia, India, Panama, Thailand, Brazil, Ireland, Peru, Turkey, Canada, Israel, Poland, United Kingdom, Chile, Italy, Portugal, United States, Colombia, Korea, Qatar, Uruguay, Costa Rica, Lebanon, Romania, Finland, Malaysia and Saudi Arabia.

    Quantity

    16,710 total all affected devices