BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only

    Recall: Z-2047-2017 · Reported May 17, 2017

    Enforcement

    Recall Number
    Z-2047-2017
    Event ID
    77049
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Sofamor Danek USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 17, 2017
    Initiation Date
    April 13, 2017
    Classification Date
    May 5, 2017
    Termination Date
    December 28, 2017
    Address
    1800 Pyramid Pl, N/A, Memphis, TN, 38132-1703, United States

    Description

    Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only

    Reason

    Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles instead of one diamond-tipped needle and one bevel-tipped needle.

    Code Info

    Lot number 0521148W, Exp. 10/21/2021

    Distribution

    US Distribution to the state of : OK and to the countries of : Italy, Germany, France , Belgium, Spain and Japan.

    Quantity

    36 units