BEUDAMED
    FDA Recall Terminated

    Microseal Master Cone Part Number: 815-9033 Microseal Master Cone is intended to obturate root canals during endodontic therapy procedures.

    Recall: Z-0160-2012 · Initiated September 9, 2010

    Recall

    Recall Number
    Z-0160-2012
    Event Number
    57234
    Firm
    Ormco Corporation
    FEI Number
    2016150
    Product Code
    EKM
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    September 9, 2010
    Posted
    November 4, 2011
    Terminated
    November 21, 2011
    Address
    1332 S Lone Hill Ave, Glendora, CA, 91740

    Description

    Microseal Master Cone Part Number: 815-9033 Microseal Master Cone is intended to obturate root canals during endodontic therapy procedures.

    Reason

    The recall was initiated because SybronEndo has confirmed that the Microseal Master Cones has been mislabeled.

    Action

    Sybron Dental Specialties, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated September 20, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to return the affected lots of product.. Products, would be replaced at no charge or credited to their account. Customers were instructed to contact SybronEndo Customer Care at 1-800-346-3636 directly to handle the arrangements of a quick return and replacement. The affected product should be returned to SybronEndo at the following address. Please label returned product "RECALLED PRODUCT Attention: Customer Returns" SybronEndo 1332 South Lone Hik Avenue Glendora, CA 91740 ADDITIONALLY, THEY KINDLY REQUEST CONSIGNEE COOPERATION IN COMPLETING AND FAXING BACK THE ENCLOSED ACKNOWLEDGEMENT/RETURN FORM. THIS FORM MUST BE COMPLETED AND RETURNED WHETHER OR NOT YOU HAVE ANY PRODUCT TO RETURN. Customers were also asked to identify and recover the affected product lots listed above that may have been shipped to their customers. For questions regarding this recall call 909-962-5600.

    Distribution

    Worldwide Distribution - USA including AR, CA, FL, PA, GA, IL, TX, WA, NY, IN, AL & MT; Internationally to Canada, CIS (Commonwealth of Independent States, Israel, United Kingdom, Sweden, France, Germany, and Italy.

    Quantity

    200 units