BEUDAMED
    FDA Enforcement Class II Terminated

    MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.

    Recall: Z-0559-2013 · Reported December 26, 2012

    Enforcement

    Recall Number
    Z-0559-2013
    Event ID
    63776
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 26, 2012
    Initiation Date
    November 5, 2012
    Classification Date
    December 19, 2012
    Termination Date
    February 21, 2014
    Address
    4900 Charlemar Dr Bldg A, Cincinnati, OH, 45227-1402, United States

    Description

    MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.

    Reason

    An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the functionality of the firm's Mayfield Composite Series Base Units and Mayfield Skull Clamps. In order to prevent additional complaint reports, the firm decided to recall and replace certain lot codes of the Base Units and Skull Clamps that were d

    Code Info

    The recalled product is identified with the Lot Numbers: 096455 and 097546.

    Distribution

    Nationwide Distribution including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA TN, TX, UT, VA, WA and WI.

    Quantity

    eight (8) skull clamps were distributed