BEUDAMED
    FDA Enforcement Class II Terminated

    Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed form a radiopaque, rapidly setting bone cement.

    Recall: Z-2606-2016 · Reported August 31, 2016

    Enforcement

    Recall Number
    Z-2606-2016
    Event ID
    74800
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Encore Medical, Lp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 31, 2016
    Initiation Date
    July 26, 2016
    Classification Date
    August 19, 2016
    Termination Date
    January 13, 2017
    Address
    9800 Metric Blvd, Austin, TX, 78758-5445, United States

    Description

    Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed form a radiopaque, rapidly setting bone cement.

    Reason

    The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not contain antibiotics.

    Code Info

    Lot 507970

    Distribution

    US Nationwide Distribution

    Quantity

    866 units