BEUDAMED
    FDA Enforcement Class II Terminated

    CoCr Head (Not distributed in the United States) Used in total hip replacement.

    Recall: Z-0072-2014 · Reported November 6, 2013

    Enforcement

    Recall Number
    Z-0072-2014
    Event ID
    65799
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2013
    Initiation Date
    August 30, 2013
    Classification Date
    October 25, 2013
    Termination Date
    September 25, 2014
    Address
    345 E Main St, N/A, Warsaw, IN, 46580-2746, United States

    Description

    CoCr Head (Not distributed in the United States) Used in total hip replacement.

    Reason

    The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.

    Code Info

    Part Number Range:01.01012.405/408

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.

    Quantity

    604064 total