BEUDAMED
    FDA Enforcement Class II Terminated

    Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium.

    Recall: Z-0779-2014 · Reported January 22, 2014

    Enforcement

    Recall Number
    Z-0779-2014
    Event ID
    67179
    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
    May 6, 2013
    Classification Date
    January 16, 2014
    Termination Date
    April 18, 2016
    Address
    4500 Riverside Drive, Palm Beach Gardens, FL, 33410-4235, United States

    Description

    Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium.

    Reason

    Product did not reach expected sterility assurance level

    Code Info

    ALL LOTS

    Distribution

    Nationwide Distribution: FL, IL, CA. IN, MI, CA, NJ, TX, NE, NC, OR, PA, TN, DC, UT, CO, MO, KY, MD, WV, NY, and MN.

    Quantity

    183