BEUDAMED
    FDA Enforcement Class II Terminated

    McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.

    Recall: Z-0547-2015 · Reported December 17, 2014

    Enforcement

    Recall Number
    Z-0547-2015
    Event ID
    69471
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Instrumed International, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 17, 2014
    Initiation Date
    September 8, 2014
    Classification Date
    December 8, 2014
    Termination Date
    November 29, 2017
    Address
    626 Cooper Ct, N/A, Schaumburg, IL, 60173-4537, United States

    Description

    McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.

    Reason

    The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.

    Code Info

    1) Instrumed Product Name: McKenzie Enlarging Burr; Instrumed Product Number: 600-00606; Trade Name: CareFusion; CareFusion Product Name: McKenzie Enlarging Burr; CareFusion Item Number: VM85-1255; Lot Number: 030411. 2) Instrumed Product Name: McKenzie Enlarging Burr; Instrumed Product Number: 600-00606; Trade Name: Boss Instruments; Boss Instruments Product Name: McKenzie Enlarging Burr; Boss InstrumentsItem Number: 74-0144; Lot Number: 060311.

    Distribution

    Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.

    Quantity

    3 McKenzie enlarging burrs