BEUDAMED
    FDA Enforcement Class II Terminated

    GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic

    Recall: Z-0130-2014 · Reported November 13, 2013

    Enforcement

    Recall Number
    Z-0130-2014
    Event ID
    66545
    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
    November 13, 2013
    Initiation Date
    October 7, 2013
    Classification Date
    November 1, 2013
    Termination Date
    August 23, 2016
    Address
    1450 E. Brooks Rd, N/A, Memphis, TN, 38116, United States

    Description

    GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic

    Reason

    Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.

    Code Info

    Batch No. 13GM11272

    Distribution

    USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.

    Quantity

    4 units