BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0566-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0566-2018
    Event ID
    78839
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Sofamor Danek USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2018
    Initiation Date
    December 22, 2017
    Classification Date
    February 9, 2018
    Termination Date
    July 31, 2018
    Address
    1800 Pyramid Pl, Memphis, TN, 38132-1703, United States

    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.

    Code Info

    UDI: 00643169363502, Lot Number EM17F015

    Distribution

    MN, NC

    Quantity

    2 units