BEUDAMED
    FDA Enforcement Class II Terminated

    VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400

    Recall: Z-1682-2016 · Reported May 25, 2016

    Enforcement

    Recall Number
    Z-1682-2016
    Event ID
    73981
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Manufacturing B.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 25, 2016
    Initiation Date
    May 4, 2016
    Classification Date
    May 16, 2016
    Termination Date
    July 5, 2017
    Address
    Turpeaux Industrial Park Rd 1 km 123.4, N/A, Mercedita, PR, 00715, United States

    Description

    VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400

    Reason

    A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

    Code Info

    LOT: 63290189

    Distribution

    Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.

    Quantity

    50