BEUDAMED
    FDA Enforcement Class II Terminated

    SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. Apply clamps parallel to the skin with the angled jaws forming a "V" shape between clamp and drape.

    Recall: Z-2316-2015 · Reported August 5, 2015

    Enforcement

    Recall Number
    Z-2316-2015
    Event ID
    71300
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Symmetry Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 5, 2015
    Initiation Date
    June 16, 2015
    Classification Date
    July 29, 2015
    Termination Date
    May 26, 2016
    Address
    3034 Owen Dr, N/A, Antioch, TN, 37013-2413, United States

    Description

    SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. Apply clamps parallel to the skin with the angled jaws forming a "V" shape between clamp and drape.

    Reason

    Lack of sterility assurance.

    Code Info

    149053, 149129, 149143, 149604, 149605, 149606, 149682, 149692, 149837, 149853, 154454, 154455, 154456, 154457, 185696, 228161, 229609, 230233, 259154, 259156, 259160, 268906, 268910, and 271548.

    Distribution

    Worldwide Distribution -- US, including the states of CA, VA, TX, FL, OH, NY, MS, KY, UT, GA, PA, MO, IN, NV, AL, MI, MA, and LA; and, the countries of Germany and Mexico.

    Quantity

    2,708 units