BEUDAMED
    FDA Enforcement Class II Terminated

    Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provisional Top Nonsterile TASP CR L 3-9 CD TOP

    Recall: Z-2298-2014 · Reported August 27, 2014

    Enforcement

    Recall Number
    Z-2298-2014
    Event ID
    68817
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 27, 2014
    Initiation Date
    June 10, 2013
    Classification Date
    August 21, 2014
    Termination Date
    September 11, 2014
    Address
    1800 W Center St, Warsaw, IN, 46580-2304, United States

    Description

    Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provisional Top Nonsterile TASP CR L 3-9 CD TOP

    Reason

    Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.

    Code Info

    Item Numbers: 42517000410 Lot Numbers: 62024975 62043546 62144792 62152725 62165538 62187318 62337961 62372407 62386776 62397159 62405917 62456263 62499170 62551386 62568272 62572572 62565051 62663168 62691384 62707494 62717346

    Distribution

    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore.

    Quantity

    70,986 distribution events