BEUDAMED
    FDA Enforcement Class II Terminated

    GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic

    Recall: Z-0446-2014 · Reported December 11, 2013

    Enforcement

    Recall Number
    Z-0446-2014
    Event ID
    66333
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 11, 2013
    Initiation Date
    August 27, 2013
    Classification Date
    December 4, 2013
    Termination Date
    August 20, 2019
    Address
    1450 E. Brooks Rd, N/A, Memphis, TN, 38116, United States

    Description

    GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic

    Reason

    The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

    Code Info

    Batch No. 12GT20822

    Distribution

    Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.

    Quantity

    80 pieces