BEUDAMED
    FDA Recall Terminated

    Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirect restorations.

    Recall: Z-1076-2013 · Initiated February 22, 2013

    Recall

    Recall Number
    Z-1076-2013
    Event Number
    64559
    Firm
    Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
    FEI Number
    2024312
    Product Code
    MZW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 22, 2013
    Posted
    April 10, 2013
    Terminated
    January 22, 2014
    Address
    1717 W Collins Ave, Orange, CA, 92867-5422

    Description

    Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirect restorations.

    Reason

    Kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite is causing the material to prematurely polymerize in the syringe. The product could be difficult to extrude or demonstrate a shorter work-time as the material may prematurely set prior to placing restorations on the tooth or core build-up. As a result, the restoration may not be seated properly.

    Action

    The firm, Kerr Corporation/Sybron Dental Specialties, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated February 22, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers are instructed to determine if you have any of the affected products in your inventory; If you have the affected lots, please contact Kerr Customer Care at 1-800-537-7123 to receive an RMA number for quick return; complete and return the Maxcem Elite Acknowledgement and Recall Return Form via fax to 714-288-4609 regardless of whether you have any product in your inventory. If you are an authorized Kerr Corporation distributor, identify and contact those customers that may have been shipped the affected product within 48 hours of receipt of this field correction notification. If you have any question, contact Kerr Customer Care at 1-800-537-7123.

    Distribution

    Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, Belgium, Czech Republic, France, Great Britain, Poland, Albania, Austria, Bulgaria, Switzerland, Cyprus, Germany, Denmark, Estonia, Spain, Finland, Croatia, Hungary, Ireland, ITtaly Luxembourg, Latvia, Netherlands, Norway, Portugal, Romania, Serbia (Republic of Serbia), Sweden, Slovenia, Turkey, Ukraine, United Arab Emirates, Congo, The Democratic Republic of the (formerly Zaire), Kazakhstan, Lebanon, Russian Federation, South Africa, Mexico, Thailand, Brazil, China, Hong Kong, Israel, India, Japan, Malaysia, Panama, Singapore, Viet Nam.

    Quantity

    40,819 kit and syringe units