BEUDAMED
    FDA Enforcement Class II Terminated

    LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.

    Recall: Z-0591-2015 · Reported December 17, 2014

    Enforcement

    Recall Number
    Z-0591-2015
    Event ID
    69759
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 17, 2014
    Initiation Date
    November 4, 2014
    Classification Date
    December 11, 2014
    Termination Date
    August 22, 2019
    Address
    1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States

    Description

    LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.

    Reason

    The stem taper on this device is undersized; the gauge point is not deep enough.

    Code Info

    Lot Number 14EM23391

    Distribution

    Worldwide Distribution: US (nationwide) including states of: MI, MN, MO, OH, PA, IA, and TN; and Internationally to: SWITZERLAND; CANADA, COLOMBIA, GERMANY, Dubai, (UAE), THAILAND; SOUTH AFRICA, SOUTH KOREA; and SINGAPORE.

    Quantity

    23 units