BEUDAMED
    FDA Enforcement Class II Terminated

    Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures.

    Recall: Z-0783-2013 · Reported February 13, 2013

    Enforcement

    Recall Number
    Z-0783-2013
    Event ID
    63793
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Anspach Effort, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 13, 2013
    Initiation Date
    September 5, 2012
    Classification Date
    February 4, 2013
    Termination Date
    August 13, 2014
    Address
    4500 Riverside Drive, N/A, Palm Beach Gardens, FL, 33410-4235, United States

    Description

    Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures.

    Reason

    Contact between the bur and bur guard could generate metal fragments that may or may not be visible to the surgeon and can potentially remain in the surgical site. The materials used to fabricate the bur guard are not traceable, design validation did not effectively evaluate adequate protection of adjacent tissue and inspection results for each of these bur guards were not documented.

    Code Info

    Lot number: 2000930

    Distribution

    Distributed in the state of Massachusetts

    Quantity

    8 devices