BEUDAMED
    FDA Enforcement Class II Terminated

    SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only

    Recall: Z-1257-2020 · Reported February 26, 2020

    Enforcement

    Recall Number
    Z-1257-2020
    Event ID
    84538
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ormco/Sybronendo
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 26, 2020
    Initiation Date
    January 17, 2020
    Classification Date
    February 18, 2020
    Termination Date
    September 30, 2024
    Address
    1332 S Lone Hill Ave, Glendora, CA, 91740-5339, United States

    Description

    SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only

    Reason

    The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure, broken/damage buccal tubes it may cause the tooth to rotate, possibly delay treatment and inconvenience the patient and clinician. If not noticed it may extend treatment by approximately 1 -3 months.

    Code Info

    All Lots UDI #s: 00889989002652 & 00889989002669

    Distribution

    US:AK,AL,AR,AZ,CA,CO,CN,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,SD,TN,TX,UT,VA,VT,WA,WI,WV,WY OUS: Argentina, Australia, Barbados, Bahamas, Bolivia, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Hong Kong, Indonesia, Japan, Cambodia, Korea, Cayman Islands, Sri Lanka, Myanmar, Mexico, Malaysia, Netherlands, Nepal, Panama, Philippines, Paraguay, Russian Federation, Singapore, Thailand, Taiwan, Uruguay, Viet Nam, South Africa

    Quantity

    3,632,493 brackets