BEUDAMED
    FDA Enforcement Class II Terminated

    symmetry surgical ULTRA(R) Sterrad container, REF numbers: C131310-SP, C13134-SP, C13135-SP, C13136-SP, C13139-SP, C13854-SP, C13855-SP, C13856-SP, C181310-SP, C18134-SP, C18135-SP, C18136-SP, C18138-SP, C22854-SP, C22855-SP, C22856-SP, C22858-SP, C24134-SP, C24135-SP, C24136-SP, C24138-SP Product Usage: sterilization container

    Recall: Z-1011-2017 · Reported January 18, 2017

    Enforcement

    Recall Number
    Z-1011-2017
    Event ID
    75850
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Symmetry Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 18, 2017
    Initiation Date
    November 29, 2016
    Classification Date
    January 11, 2017
    Termination Date
    August 20, 2017
    Address
    3034 Owen Dr, Antioch, TN, 37013-2413, United States

    Description

    symmetry surgical ULTRA(R) Sterrad container, REF numbers: C131310-SP, C13134-SP, C13135-SP, C13136-SP, C13139-SP, C13854-SP, C13855-SP, C13856-SP, C181310-SP, C18134-SP, C18135-SP, C18136-SP, C18138-SP, C22854-SP, C22855-SP, C22856-SP, C22858-SP, C24134-SP, C24135-SP, C24136-SP, C24138-SP Product Usage: sterilization container

    Reason

    Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-sterilization.

    Code Info

    All

    Distribution

    Worldwide Distribution

    Quantity

    149 units