BEUDAMED
    FDA Enforcement Class III Terminated

    ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma or requested during reconstructive surgery.

    Recall: Z-1233-2014 · Reported March 26, 2014

    Enforcement

    Recall Number
    Z-1233-2014
    Event ID
    67194
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet 3i, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 26, 2014
    Initiation Date
    October 3, 2013
    Classification Date
    March 19, 2014
    Termination Date
    December 11, 2014
    Address
    4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200, United States

    Description

    ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma or requested during reconstructive surgery.

    Reason

    Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number.

    Code Info

    Model # ROX05, Batch # S0171051

    Distribution

    Worldwide Distribution - USA including CA, DC, FL, LA, MA, MO, NC, NJ, NY, TX, VA, WA and Hawaii and Internatially to Austria, Belgium, Canada, Switzerland, Germany, Spain, France, Great Britain (UK), Ireland, Mexico, Poland, Portugal, and Singapore.

    Quantity

    704