BEUDAMED
    FDA Enforcement Class II Terminated

    ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.

    Recall: Z-1574-2014 · Reported May 21, 2014

    Enforcement

    Recall Number
    Z-1574-2014
    Event ID
    68109
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Anspach Effort, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 21, 2014
    Initiation Date
    January 8, 2014
    Classification Date
    May 9, 2014
    Termination Date
    January 20, 2015
    Address
    4500 Riverside Drive, Palm Beach Gardens, FL, 33410-4235, United States

    Description

    ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.

    Reason

    Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product.

    Code Info

    Lot/Set/Serial: G323081803.

    Distribution

    Nationwide Distribution including FL, TX, NC, IL, CO, and PA.

    Quantity

    30 cutting burs affected