BEUDAMED
    FDA Enforcement Class II Terminated

    Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.

    Recall: Z-0424-2015 · Reported December 3, 2014

    Enforcement

    Recall Number
    Z-0424-2015
    Event ID
    69366
    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
    December 3, 2014
    Initiation Date
    October 14, 2014
    Classification Date
    November 23, 2014
    Termination Date
    June 9, 2015
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.

    Reason

    To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor pad fracture.

    Code Info

    Item 00-5953-056-06; all lots

    Distribution

    Worldwide Distribution - US Nationwide in the state of AL, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, ND, NH, NJ, NV, NY, OH, OR, PA, SC, TX, VA, WI, NC, TN, OK, AZ, UT, AK, PR, DC. and the countries of: Germany, China, Canada, Australia, Japan, United Arab Emirates, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Iceland, Italy, Malta, Netherlands, Norway, Poland, Russian Fed., Saudi Arabia, Sweden, Slovakia, and South Africa.

    Quantity

    4961 units