BEUDAMED
    FDA Enforcement Class II Terminated

    PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.

    Recall: Z-1712-2014 · Reported June 11, 2014

    Enforcement

    Recall Number
    Z-1712-2014
    Event ID
    68326
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microport Orthopedics INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 11, 2014
    Initiation Date
    April 30, 2014
    Classification Date
    June 4, 2014
    Termination Date
    December 1, 2014
    Address
    5677 Airline Rd, Arlington, TN, 38002-9501, United States

    Description

    PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.

    Reason

    Difficulty removing the cup adaptor from the impaction handle during surgery

    Code Info

    Lot Number(s): 1153896, 1279714, 1288604, and 1314793

    Distribution

    Nationwide Distribution.

    Quantity

    140 units