BEUDAMED
    FDA Enforcement Class II Terminated

    Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. Product Usage: An orthodontic bracket. Spirit MB Brackets are a fixed attachment on a tooth which holds an archwire during orthodontic treatment.

    Recall: Z-1330-2014 · Reported April 9, 2014

    Enforcement

    Recall Number
    Z-1330-2014
    Event ID
    67849
    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 3, 2014
    Termination Date
    April 18, 2014
    Address
    1332 S Lone Hill Ave, N/A, Glendora, CA, 91740-5339, United States

    Description

    Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. Product Usage: An orthodontic bracket. Spirit MB Brackets are a fixed attachment on a tooth which holds an archwire during orthodontic treatment.

    Reason

    Ormco Corporation initiated this recall of Spirit MB Brackets, Part Number 494-0110, Lot Number 081351013, because the ID dot, which designates the bracket as distal/gingival, is misplaced. The misidentification may lead an orthodontist to place the bracket on the wrong tooth, leading to movement 10 degrees in the wrong direction.

    Code Info

    Part Number 494-0110, Lot Number 081351013.

    Distribution

    Internationally Distributed in the country of Japan.

    Quantity

    150 units