BEUDAMED
    FDA Recall 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 · Initiated May 4, 2016

    Recall

    Recall Number
    Z-1678-2016
    Event Number
    73981
    FEI Number
    1000132037
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    May 4, 2016
    Posted
    May 16, 2016
    Terminated
    July 5, 2017
    Address
    Zimmer Manufacturing B.V. Turpeaux Industrial Park Rd 1 km 123.4, Mercedita, PR, 00715

    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.

    Action

    All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.

    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