BEUDAMED
    FDA Enforcement Class II Terminated

    .***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only Product Usage: Cutting and shaping bone including bones of the spine and cranium.

    Recall: Z-2077-2012 · Reported August 1, 2012

    Enforcement

    Recall Number
    Z-2077-2012
    Event ID
    62326
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Anspach Effort, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 1, 2012
    Initiation Date
    September 19, 2011
    Classification Date
    July 25, 2012
    Termination Date
    July 25, 2013
    Address
    4500 Riverside Drive, Palm Beach Gardens, FL, 33410-4235, United States

    Description

    .***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only Product Usage: Cutting and shaping bone including bones of the spine and cranium.

    Reason

    Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Single Use Sterile Bone Cutting Burrs used with XMax, microMax, microMax Plus, eMax, eMax2 and eMax2 Plus High Speed Drill Systems. It is possible for the cutter to come apart.

    Code Info

    Lot numbers E203050779 and E383055709.

    Distribution

    US Nationwide Distribution including the states of: Arizona. and California.

    Quantity

    5 each