BEUDAMED
    FDA Enforcement Class II Terminated

    G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.

    Recall: Z-2839-2016 · Reported September 28, 2016

    Enforcement

    Recall Number
    Z-2839-2016
    Event ID
    75121
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Anspach Effort, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 28, 2016
    Initiation Date
    August 26, 2016
    Classification Date
    September 16, 2016
    Termination Date
    November 29, 2017
    Address
    4500 Riverside Dr, Palm Beach Gardens, FL, 33410-4235, United States

    Description

    G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.

    Reason

    The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503.

    Code Info

    Material M-3SB-2-G1 Batch J316017640

    Distribution

    AZ, DC, CA, MD, MI, and OR Switzerland

    Quantity

    63