BEUDAMED
    FDA Recall 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 · Initiated November 4, 2015

    Recall

    Recall Number
    Z-0343-2016
    Event Number
    72590
    Firm
    Ormco/Sybronendo
    FEI Number
    2016150
    Product Code
    DZC
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    November 4, 2015
    Posted
    November 30, 2015
    Terminated
    January 19, 2016
    Address
    1332 S Lone Hill Ave, Glendora, CA, 91740-5339

    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.

    Action

    A recall letter dated 11/5/15 was sent to all their customers who purchased the Copper NiTi Preformed Archwires because it has been brought to Ormco's attention that the product transformation temperature as listed on the labeling is incorrect. The wire is labeled as having 40 degrees Celsius transformation temperature, but the actual wire has a transformation temperature of 29 degrees Celsius. The letter provides the customers with the problems identified and the actions to be taken. Customers are instructed to complete and fax back the enclosed acknowledgement form.

    Distribution

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

    Quantity

    161 units