BEUDAMED
    FDA Recall Terminated

    Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4210 Lot Number100512025 and 100512020

    Recall: Z-0203-06 · Initiated November 3, 2005

    Recall

    Recall Number
    Z-0203-06
    Event Number
    34016
    Firm
    Ormco Corporation
    FEI Number
    2016150
    Product Code
    DYW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 3, 2005
    Posted
    November 26, 2005
    Terminated
    January 11, 2006
    Address
    1332 S Lone Hill Ave, Glendora, CA, 91740-5339

    Description

    Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4210 Lot Number100512025 and 100512020

    Reason

    Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.

    Action

    Telephone notification will be followed by letters sent via U.S. first class mail with mailing to commence on Thursday, 11/3/05.

    Distribution

    Nationwide

    Quantity

    1560