BEUDAMED
    FDA Recall Terminated

    Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are included in recall. Part Number MCA Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.

    Recall: Z-0749-2014 · Initiated March 29, 2012

    Recall

    Recall Number
    Z-0749-2014
    Event Number
    63624
    Firm
    The Anspach Effort, Inc.
    FEI Number
    1045834
    Product Code
    HBE
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    March 29, 2012
    Posted
    January 15, 2014
    Terminated
    March 11, 2015
    Address
    4500 Riverside Drive, Palm Beach Gardens, FL, 33410-4235

    Description

    Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are included in recall. Part Number MCA Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.

    Reason

    The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decide

    Action

    Firm is performing a Medical Device Recall by sending customers a recall letter and requesting the return of Anspach Micro Curved Attachments and Dissection Tools currently on hand.

    Distribution

    Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.

    Quantity

    163