BEUDAMED
    FDA Enforcement Class II Terminated

    Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 75 mm Length 47115507507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 90 mm Length 47115509007

    Recall: Z-1680-2016 · Reported May 25, 2016

    Enforcement

    Recall Number
    Z-1680-2016
    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

    Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 75 mm Length 47115507507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 90 mm Length 47115509007

    Reason

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

    Code Info

    LOTS: 63303808 63292589 63292588

    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

    90