BEUDAMED
    FDA Enforcement Class II Terminated

    Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.

    Recall: Z-0343-2016 · Reported December 9, 2015

    Enforcement

    Recall Number
    Z-0343-2016
    Event ID
    72590
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ormco/Sybronendo
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 9, 2015
    Initiation Date
    November 4, 2015
    Classification Date
    November 30, 2015
    Termination Date
    January 19, 2016
    Address
    1332 S Lone Hill Ave, Glendora, CA, 91740-5339, United States

    Description

    Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.

    Reason

    Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.

    Code Info

    Lot No. 21538339

    Distribution

    Distributed US (nationwide) and the countries of Canada, Japan, Mexico, Russia, and Peru.

    Quantity

    161 units