BEUDAMED
    FDA Recall Terminated

    OMNI K1 Broach Handle, Product Code HS-10054

    Recall: Z-0837-2019 · Initiated November 29, 2018

    Recall

    Recall Number
    Z-0837-2019
    Event Number
    81951
    Firm
    OMNIlife science Inc.
    FEI Number
    3008342029
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 29, 2018
    Terminated
    April 16, 2020
    Address
    480 Paramount Dr, Raynham, MA, 02767-1085

    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.

    Action

    Customers were contacted via telephone on 11/29/18. Advisory Notice letters were also distributed to customers on 12/14/18.

    Distribution

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

    Quantity

    7