BEUDAMED
    FDA Enforcement Class II Terminated

    GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic

    Recall: Z-1996-2013 · Reported August 28, 2013

    Enforcement

    Recall Number
    Z-1996-2013
    Event ID
    65738
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 28, 2013
    Initiation Date
    July 8, 2013
    Classification Date
    August 21, 2013
    Termination Date
    August 19, 2019
    Address
    1450 E. Brooks Rd, N/A, Memphis, TN, 38116, United States

    Description

    GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic

    Reason

    The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts).

    Code Info

    Lot Number 12LM03798

    Distribution

    International only: Germany, France, United Arab Emirates, and United Kingdom.

    Quantity

    9 units