BEUDAMED
    FDA Enforcement Class II Terminated

    Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19

    Recall: Z-2262-2018 · Reported June 27, 2018

    Enforcement

    Recall Number
    Z-2262-2018
    Event ID
    80099
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TriMed Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 27, 2018
    Initiation Date
    April 13, 2018
    Classification Date
    June 20, 2018
    Termination Date
    January 22, 2021
    Address
    27533 Avenue Hopkins, N/A, Santa Clarita, CA, 91355-3910, United States

    Description

    Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19

    Reason

    During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.

    Code Info

    Lot #: a) R901, 03UU, 050522, 10505-22, 0344, 0051, 11805, 00AJ, 10505-23, 050523, 180502, 180901, 180503, 18902; b) 03UV, 050523, 10505-23, 00AJ, 0052, 180901, 11809, 180902, 26408, 264-08, 11805, 180502, 118901

    Distribution

    U.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL; OUS: Australia and Sweden

    Quantity

    532