BEUDAMED
    FDA Recall Terminated

    MAYFIELD Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar Drive, Building A, Cincinnati, OH 45227 The MAYFIELD Base Units are intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.

    Recall: Z-0869-2013 · Initiated December 21, 2012

    Recall

    Recall Number
    Z-0869-2013
    Event Number
    64185
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    FWZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 21, 2012
    Posted
    February 21, 2013
    Terminated
    July 10, 2013
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    MAYFIELD Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar Drive, Building A, Cincinnati, OH 45227 The MAYFIELD Base Units are intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.

    Reason

    Integra determined there is a possibility that the Base Units may break during use.

    Action

    Integra LifeSciences Corporation sent an Urgent Medical Device Recall letter dated December 21, 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 stop using the affected product immediately and also remove them from service to prevent any further use of the affected product. Integra would provide an alternative base unit to replace those customers could no longer use. Customers were asked to complete the Recall Acknowledgement and Return Form to ensure they received this information. For assistance customers were instructed to call 1-513-533-7944 or 1-513-533-7946

    Distribution

    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA & WI. Internationally to Belgium.

    Quantity

    96 units