BEUDAMED
    FDA Enforcement Class II Terminated

    Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.

    Recall: Z-1948-2015 · Reported July 8, 2015

    Enforcement

    Recall Number
    Z-1948-2015
    Event ID
    71531
    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
    July 8, 2015
    Initiation Date
    October 2, 2014
    Classification Date
    July 1, 2015
    Termination Date
    July 1, 2015
    Address
    1800 W Center St, Warsaw, IN, 46580-2304, United States

    Description

    Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.

    Reason

    Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. If the outer tray is compromised in addition to the inner tray a periprosthetic infection may occur. The risk associated with a periprosthetic infection is a revision or potential multi-stage revision to treat the infection.

    Code Info

    item 6215-12-185 Lots: 7884165 7884736 7884737 7884738 7890330 11011448 11012660 60394169 60415420 60515793 60564530 60601129 60614014 60797044 60803056 60841848 60922655 60922656 60927853 60989112 61017152 61104192 61135872 61200531 61284571 61366919 61464308 61505310 61533025 61566733 61742151 61780361 61784264 61834192 61834778 61840307 61930376 61947884 61947885 62097910 62146925 62195165 62249431 62281270 62305675 62317987 62358643 62448678 62536901 62536902 62536903 62546527 62560372 62587577 62610989 62624715 62624716 62624717 62624718 62709664 62709665 62709667 62709670

    Distribution

    US Nationwide Distribution, including DC and the states of AL, AZ, CA, CO, FL, GA, IL, IN, KS, LA, MD, MI, MN, MO, MT, NC, ND, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, and WY.

    Quantity

    352