BEUDAMED
    FDA Recall Terminated

    Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only

    Recall: Z-0566-2018 · Initiated December 22, 2017

    Recall

    Recall Number
    Z-0566-2018
    Event Number
    78839
    Firm
    Medtronic Sofamor Danek USA Inc
    FEI Number
    1000477302
    Product Code
    MDM
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 22, 2017
    Terminated
    July 31, 2018
    Address
    1800 Pyramid Pl, Memphis, TN, 38132-1703

    Description

    Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only

    Reason

    Medtronic has discovered the product lot in question was noted as having a longer drill tip extension than what is indicated on the print specification.

    Action

    The firm initiated the recall by letter on 12/22/2017, requesting the return of the product.

    Distribution

    MN, NC

    Quantity

    2 units