BEUDAMED
    FDA Enforcement Class II Terminated

    NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee arthroplasty when there is insufficient bone in the distal femur.

    Recall: Z-1575-2015 · Reported May 13, 2015

    Enforcement

    Recall Number
    Z-1575-2015
    Event ID
    71009
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 13, 2015
    Initiation Date
    April 2, 2015
    Classification Date
    May 1, 2015
    Termination Date
    September 23, 2015
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee arthroplasty when there is insufficient bone in the distal femur.

    Reason

    The affected lot is being recalled because it was packaged without the locking screw. The locking screw packaged with the augment is used to fix the augment to the femoral component. This has the potential to delay surgery

    Code Info

    Part #00-5990-036-10; lot 62815809

    Distribution

    Distributed in the states of IN, MN, FL, and IL, and the countries of Argentina and Germany.

    Quantity

    20 units