BEUDAMED
    FDA Recall Terminated

    Titanium Orthos Bracket

    Recall: Z-0309-05 · Initiated November 18, 2004

    Recall

    Recall Number
    Z-0309-05
    Event Number
    30515
    Firm
    Ormco Corporation
    FEI Number
    2016150
    Product Code
    EJF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 18, 2004
    Posted
    December 15, 2004
    Terminated
    June 17, 2005
    Address
    1332 S Lone Hill Ave, Glendora, CA, 91740-5339

    Description

    Titanium Orthos Bracket

    Reason

    Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed.

    Action

    Recall letters were mailed from 11/18 thru 11/23. Letters request return of product.

    Distribution

    Nationwide and France, Luxembourg, Spain, Netherlands, Russia, Ireland, Italy, Germany, United Kingdom, Hungary, Finland, Denmark.

    Quantity

    6,257