BEUDAMED
    FDA Enforcement Class II Terminated

    M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 00225307042

    Recall: Z-1678-2016 · Reported May 25, 2016

    Enforcement

    Recall Number
    Z-1678-2016
    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

    M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 00225307042

    Reason

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

    Code Info

    LOTS: 63295051 63293672

    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

    219