BEUDAMED
    FDA Recall Terminated

    Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15

    Recall: Z-2265-2018 · Initiated April 13, 2018

    Recall

    Recall Number
    Z-2265-2018
    Event Number
    80099
    Firm
    TriMed Inc.
    FEI Number
    3001236812
    Product Code
    JDR
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    April 13, 2018
    Terminated
    January 22, 2021
    Address
    27533 Avenue Hopkins, Santa Clarita, CA, 91355-3910

    Description

    Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15

    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.

    Action

    On 04/13/18, customer recall communication forms were sent via mail informing customers to quarantine effected devices, call the manufacturer to arrange device return at 800-633-7221, and report adverse events to the FDA's MedWatch.

    Distribution

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

    Quantity

    1,194