BEUDAMED
    FDA Enforcement Class II Terminated

    Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.

    Recall: Z-0118-2021 · Reported October 28, 2020

    Enforcement

    Recall Number
    Z-0118-2021
    Event ID
    86496
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 28, 2020
    Initiation Date
    September 21, 2020
    Classification Date
    October 16, 2020
    Termination Date
    May 22, 2026
    Address
    1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States

    Description

    Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.

    Reason

    The anterior locking detail does not meet its design specifications.

    Code Info

    Model: 71420966, Lot: 18JY09702

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of CA, NH, NY, GA, MI, TX, IL, OK, LA, OR, FL, AZ, NJ, MO and the countries of AE. BE, BR, CO, DE, ES, FR, GB, HU, IT, PL, PT, TR.

    Quantity

    47 devices