BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0715-2014 · Initiated March 29, 2012

    Recall

    Recall Number
    Z-0715-2014
    Event Number
    67177
    Firm
    The Anspach Effort, Inc.
    FEI Number
    1045834
    Product Code
    HBE
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    March 29, 2012
    Posted
    January 10, 2014
    Terminated
    October 12, 2017
    Address
    4500 Riverside Drive, Palm Beach Gardens, FL, 33410-4235

    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.

    Action

    Anspach sent an Urgent Medical Device Labeling Correction letter dated Marach 29,, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to include the item 18-0079 with their inventory immediately, complete the attached reply form indicating their receipt of the letter. Return the completed form by fax to the number or email provided on the form. If product was further distributed to other facilities, the correction letter should be forwarded to them. Customers with quesitons should call 1-800-327-6887 or email [email protected] or [email protected]. For questions regarding this recall call 561-627-1020.

    Distribution

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

    Quantity

    492 (321 US)