BEUDAMED
    FDA Enforcement Class II Terminated

    Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures

    Recall: Z-0715-2014 · Reported January 22, 2014

    Enforcement

    Recall Number
    Z-0715-2014
    Event ID
    67177
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Anspach Effort, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2014
    Initiation Date
    March 29, 2012
    Classification Date
    January 10, 2014
    Termination Date
    October 12, 2017
    Address
    4500 Riverside Drive, Palm Beach Gardens, FL, 33410-4235, United States

    Description

    Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures

    Reason

    Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs.

    Code Info

    ALL LOTS for product code 18-0001

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Great Britain, Australia, Switzerland, Sweden, France, Japan, Spain, Italy, Canada, and Netherlands.

    Quantity

    492 (321 US)