BEUDAMED
    FDA Enforcement Class II Ongoing

    TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

    Recall: Z-0357-2020 · Reported November 20, 2019

    Enforcement

    Recall Number
    Z-0357-2020
    Event ID
    83820
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    TriMed Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2019
    Initiation Date
    September 28, 2018
    Classification Date
    November 12, 2019
    Address
    27533 Avenue Hopkins, N/A, Santa Clarita, CA, 91355-3910, United States

    Description

    TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

    Reason

    The epoxy on Apex manufactured epoxy-coated instruments can pop off.

    Code Info

    Lot numbers 91500604 and 91600017

    Distribution

    Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.

    Quantity

    467 hex drivers