BEUDAMED
    FDA Recall Terminated

    Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation, Orange, CA.

    Recall: Z-0916-2010 · Initiated February 23, 2009

    Recall

    Recall Number
    Z-0916-2010
    Event Number
    53431
    Firm
    Sybron Dental Specialties
    FEI Number
    2024312
    Product Code
    EBF
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 23, 2009
    Posted
    March 2, 2010
    Terminated
    March 19, 2012
    Address
    1717 W Collins Ave, Orange, CA, 92867-5422

    Description

    Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation, Orange, CA.

    Reason

    Sybron Dental Specialties is initiating a field correction on the Herculite Ultra, a dental composite restorative material, due to a mistake in the directions for use located in the Herculite technique card.

    Action

    Kerr Corporation issued a letter dated February 23, 2009. Users were informed of the affected product and instructed on proper return. For further information, contact Kerr Customer Care at 1-800-537-7123.

    Distribution

    Nationwide distribution

    Quantity

    442