BEUDAMED
    FDA Enforcement Class II Terminated

    ZIMTRON 6 DEG 22 HEADS

    Recall: Z-1030-2014 · Reported February 26, 2014

    Enforcement

    Recall Number
    Z-1030-2014
    Event ID
    66500
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 26, 2014
    Initiation Date
    October 11, 2013
    Classification Date
    February 20, 2014
    Termination Date
    April 14, 2017
    Address
    345 E Main St, Warsaw, IN, 46580-2746, United States

    Description

    ZIMTRON 6 DEG 22 HEADS

    Reason

    Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.

    Code Info

    61841123

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.

    Quantity

    7,044,680 total