BEUDAMED
    FDA Enforcement Class II Terminated

    Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI

    Recall: Z-0367-2013 · Reported November 28, 2012

    Enforcement

    Recall Number
    Z-0367-2013
    Event ID
    52634
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NuVasive Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 28, 2012
    Initiation Date
    January 5, 2009
    Classification Date
    November 19, 2012
    Termination Date
    November 19, 2012
    Address
    7475 Lusk Blvd, N/A, San Diego, CA, 92121-5707, United States

    Description

    Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI

    Reason

    The tulip portion of the screw assembly can disengage from the shank after implantation.

    Code Info

    Batch: JK1949, JK2068, JK2071, JK2078, JK2079, JK2170, JK2206, JK2375, JK2387, JK2398, JK2400

    Distribution

    Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.

    Quantity

    240 units total