BEUDAMED
    FDA Enforcement Class II Terminated

    CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.

    Recall: Z-0062-2013 · Reported October 24, 2012

    Enforcement

    Recall Number
    Z-0062-2013
    Event ID
    63124
    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
    October 24, 2012
    Initiation Date
    September 13, 2012
    Classification Date
    October 15, 2012
    Termination Date
    January 15, 2014
    Address
    345 E Main St, N/A, Warsaw, IN, 46580-2746, United States

    Description

    CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.

    Reason

    Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petite (item 00-8011-000-05; ) and CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10 ) because devices were packaged in incorrect cartons and distributed internationally and domestically. Zimmer received five complaints of this packaging issue.

    Code Info

    Item 00-8114-001-10, lots 61947699 and 61952551

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of Indiana and Oklahoma and the countries of Australia, Thailand, Malaysia, Germany, India, Bulgaria, Egypt, UK, Russian FED, Slovak, and Brazil.

    Quantity

    59 both lots