BEUDAMED
    FDA Recall Terminated

    Heraeus Kulzer brand P2 Magnum 360 Trial Kit Monophase; catalog number 66009582.

    Recall: Z-0627-05 · Initiated November 1, 2003

    Recall

    Recall Number
    Z-0627-05
    Event Number
    29993
    Firm
    Heraeus Kulzer Inc.
    FEI Number
    1821514
    Product Code
    ELW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 1, 2003
    Posted
    March 15, 2005
    Terminated
    April 5, 2005
    Address
    4315 S Lafayette Blvd, South Bend, IN, 46614-2517

    Description

    Heraeus Kulzer brand P2 Magnum 360 Trial Kit Monophase; catalog number 66009582.

    Reason

    Packaging defects could result in improper mixing ratios and unusable impressions.

    Action

    Customers were notified via undated letter on or about November 1, 2003 and instructed to return product on hand..

    Distribution

    Nationwide.

    Quantity

    608 bags.