BEUDAMED
    FDA Enforcement Class II Terminated

    Dynesys¿ L.I.S. Stabilizing cord Rx, Sterile

    Recall: Z-0238-2013 · Reported November 14, 2012

    Enforcement

    Recall Number
    Z-0238-2013
    Event ID
    63103
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 14, 2012
    Initiation Date
    September 4, 2012
    Classification Date
    November 6, 2012
    Termination Date
    April 16, 2014
    Address
    345 E Main St, N/A, Warsaw, IN, 46580-2746, United States

    Description

    Dynesys¿ L.I.S. Stabilizing cord Rx, Sterile

    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

    Code Info

    REF Numbers: 01.03711.100 and 01.03711.200 Lot2290106, 2322753, 2322757, 2325303, 2328500, 2350135, 2363929, 2363972, 2366663, 2377045, 2391793, 2409738, 2422397, 2444114, 2448948, 2453742

    Distribution

    Nationwide Distribution.

    Quantity

    973