BEUDAMED
    FDA Enforcement Class II Terminated

    OMNI K1 Broach Handle, Product Code HS-10054

    Recall: Z-0837-2019 · Reported February 20, 2019

    Enforcement

    Recall Number
    Z-0837-2019
    Event ID
    81951
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    OMNIlife science Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 20, 2019
    Initiation Date
    November 29, 2018
    Classification Date
    February 14, 2019
    Termination Date
    April 16, 2020
    Address
    480 Paramount Dr, N/A, Raynham, MA, 02767-1085, United States

    Description

    OMNI K1 Broach Handle, Product Code HS-10054

    Reason

    There is a potential for the inner pin of the handle to become loose and fall out.

    Code Info

    Lot Number MM0118

    Distribution

    The products were distributed to the following US states: CA, GA, SC, and UT.

    Quantity

    7