BEUDAMED
    FDA Enforcement Class II Terminated

    ANSPACH - 4MM Fluted Ball, Extends 27MM; REF M-4B-27-G1. Cutting shaping bone including spine and cranium.

    Recall: Z-2302-2015 · Reported August 5, 2015

    Enforcement

    Recall Number
    Z-2302-2015
    Event ID
    71212
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Anspach Effort, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 5, 2015
    Initiation Date
    April 13, 2015
    Classification Date
    July 29, 2015
    Termination Date
    August 25, 2016
    Address
    4500 Riverside Dr, N/A, Palm Beach Gardens, FL, 33410-4235, United States

    Description

    ANSPACH - 4MM Fluted Ball, Extends 27MM; REF M-4B-27-G1. Cutting shaping bone including spine and cranium.

    Reason

    G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.

    Code Info

    REF M-4B-27-G1 ; ALL lot numbers.

    Distribution

    Worldwide Distribution - US including AZ, CA, CO, FL, GA, IL, KY, LA, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and Internationally to Canada and China.

    Quantity

    88 tools.