BEUDAMED
    FDA Enforcement Class II Terminated

    NGK Stem Ext 24 x 245mm

    Recall: Z-0590-2014 · Reported January 8, 2014

    Enforcement

    Recall Number
    Z-0590-2014
    Event ID
    66499
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 8, 2014
    Initiation Date
    November 5, 2013
    Classification Date
    December 27, 2013
    Termination Date
    May 5, 2015
    Address
    345 E Main St, Warsaw, IN, 46580-2746, United States

    Description

    NGK Stem Ext 24 x 245mm

    Reason

    Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure

    Code Info

    Item Numbers: 32-5988-012-24 All lots with an expiration date prior to July 24, 2023

    Distribution

    Worldwide Distribution.

    Quantity

    42, 065 units total