BEUDAMED
    FDA Recall 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 · Initiated September 13, 2012

    Recall

    Recall Number
    Z-0062-2013
    Event Number
    63124
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    JDI
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    September 13, 2012
    Posted
    October 15, 2012
    Terminated
    January 15, 2014
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    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.

    Action

    Zimmer Inc. sent an "URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC" letter dated September 13, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Consignees were asked to return all recalled product with a completed Inventory Return Certification Form. Contact the firm at 1-800-348-2759 for questions regarding this notice.

    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