BEUDAMED
    FDA Recall Terminated

    Brand name: Maxcem Elite, Product: a dental cement, Part Number: 34418. The intended use of this device is for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bridges, posts and veneers. Additional Indications include core-buildup material, pit and fissure sealant and cementation of crown restorations to implants

    Recall: Z-0915-2012 · Initiated February 3, 2011

    Recall

    Recall Number
    Z-0915-2012
    Event Number
    60685
    Firm
    Kerr Corporation
    FEI Number
    2024312
    Product Code
    MZW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 3, 2011
    Posted
    January 27, 2012
    Terminated
    January 31, 2012
    Address
    1717 W Collins Ave, Orange, CA, 92867-5422

    Description

    Brand name: Maxcem Elite, Product: a dental cement, Part Number: 34418. The intended use of this device is for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bridges, posts and veneers. Additional Indications include core-buildup material, pit and fissure sealant and cementation of crown restorations to implants

    Reason

    The recall was initiated because Kerr Corporation has confirmed that the use of the affected lot of Maxcem Elite may not provide users with a minimum of 2 minutes of worktime thereby causing the product to prematurely set by 15 seconds.

    Action

    Kerr Corporation sent a Urgent Medical Device Recall letter dated March 14, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It has recently come to our attention that use of the affected lot of product may not provide users with a minimum of 2 minutes of worktime thereby causing the product to prematurely set by 15 seconds. If this were to happen prior to placing restorations on the tooth or core build-up the restorations may not adhere properly. If you have any of the affected product listed above please contact Kerr Customer Care at 1-800-537-7123 to receive an RMA number. The RMA will allow for a quick return and replacement or credit. Please fax back the enclosed Recall Return Form in order to confirm your receipt of this recall notification regardless of whether you have any product in your inventory.

    Distribution

    Worldwide Distribution -- USA (nationwide) and the countries of Canada, Australia and New Zealand.

    Quantity

    Four hundred and sixty-three (463)