BEUDAMED
    FDA Enforcement Class II Terminated

    TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component.

    Recall: Z-1496-2014 · Reported April 30, 2014

    Enforcement

    Recall Number
    Z-1496-2014
    Event ID
    67795
    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
    April 30, 2014
    Initiation Date
    April 1, 2014
    Classification Date
    April 24, 2014
    Termination Date
    September 11, 2014
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component.

    Reason

    The shell was missing the locking ring.

    Code Info

    00-6202-060-22; lot 62490588

    Distribution

    Worldwide Distribution: US (nationwide) in states of: US: GA, WI, NJ, CA, NY, NC, PA, FL, CT, ME, TX, and IL; and countries of: Australia and Canada.

    Quantity

    17 units