BEUDAMED
    FDA Enforcement Class II Terminated

    Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.

    Recall: Z-1321-2014 · Reported April 9, 2014

    Enforcement

    Recall Number
    Z-1321-2014
    Event ID
    67861
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ormco/Sybronendo
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 9, 2014
    Initiation Date
    March 25, 2014
    Classification Date
    April 2, 2014
    Termination Date
    October 27, 2014
    Address
    1332 S Lone Hill Ave, N/A, Glendora, CA, 91740-5339, United States

    Description

    Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.

    Reason

    Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, Lot Number 121359169, because the color ID dot was marked on the wrong tie-wing of the brackets.

    Code Info

    Part Number 449-6212, Lot Number 121359169.

    Distribution

    US and Canada.

    Quantity

    150 units