BEUDAMED
    FDA Enforcement Class II Terminated

    VI DBL OFFST W/ LRG STPL, LT Nonsterile

    Recall: Z-2219-2014 · Reported August 20, 2014

    Enforcement

    Recall Number
    Z-2219-2014
    Event ID
    68656
    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
    August 20, 2014
    Initiation Date
    July 23, 2014
    Classification Date
    August 14, 2014
    Termination Date
    September 15, 2015
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    VI DBL OFFST W/ LRG STPL, LT Nonsterile

    Reason

    The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

    Code Info

    Item Number 82016757841 Lot Number 97009219, 97009254

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.

    Quantity

    412 units