BEUDAMED
    FDA Recall Terminated

    Dynesys Set screw M6

    Recall: Z-0236-2013 · Initiated September 4, 2012

    Recall

    Recall Number
    Z-0236-2013
    Event Number
    63103
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    NQP
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    September 4, 2012
    Posted
    November 6, 2012
    Terminated
    April 16, 2014
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Dynesys Set screw M6

    Reason

    Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info

    Action

    Zimmer, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated September 4, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Certificate of Acknowledgement Form was attached for customers to complete and return via fax to Zimmer, Inc. at 574 372-4265.

    Distribution

    Nationwide Distribution.

    Quantity

    58