BEUDAMED
    FDA Enforcement Class II Terminated

    ***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.

    Recall: Z-1377-2013 · Reported June 5, 2013

    Enforcement

    Recall Number
    Z-1377-2013
    Event ID
    64886
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Anspach Effort, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 5, 2013
    Initiation Date
    March 4, 2011
    Classification Date
    May 24, 2013
    Termination Date
    December 17, 2013
    Address
    4500 Riverside Drive, N/A, Palm Beach Gardens, FL, 33410-4235, United States

    Description

    ***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.

    Reason

    Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.

    Code Info

    Lots numbers: D433040800, D403040236, D383039472.

    Distribution

    Worldwide Distribution-USA (nationwide) including DC and the states of OH, TX, IL, CA, GA, KY, FL, WI, NC, VA, WI, MN, MD, KS, OK, PA, OR ,HI, AZ, WA, TN, AR, IA, MI, CO, LA, NJ, IN, WV, MO, AL, NY, VT, and SC and the countries of France, Canada, Great Britain, Mexico, Australia, Sweden and Netherlands.

    Quantity

    1,827 burrs