BEUDAMED
    FDA Enforcement Class II Terminated

    TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment

    Recall: Z-1083-2016 · Reported March 16, 2016

    Enforcement

    Recall Number
    Z-1083-2016
    Event ID
    73293
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ormco/Sybronendo
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 16, 2016
    Initiation Date
    February 8, 2016
    Classification Date
    March 8, 2016
    Termination Date
    August 30, 2016
    Address
    1332 S Lone Hill Ave, N/A, Glendora, CA, 91740-5339, United States

    Description

    TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment

    Reason

    Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner generic label is identified as ML3. The products outer package is identified as SM3 which matches the product inside.

    Code Info

    GE15011637

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Mexico, Europe, Hong Kong, MY, IN, JP, ID, SG, TH

    Quantity

    5,568 units total (2,070 units in US)