BEUDAMED
    FDA Recall 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 · Initiated February 8, 2016

    Recall

    Recall Number
    Z-1083-2016
    Event Number
    73293
    Firm
    Ormco/Sybronendo
    FEI Number
    2016150
    Product Code
    EKM
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    February 8, 2016
    Terminated
    August 30, 2016
    Address
    1332 S Lone Hill Ave, Glendora, CA, 91740-5339

    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.

    Action

    An Urgent Medical Device Recall letter dated February 8, 2016 was sent to all customers. The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and fax back the enclosed acknowledgement form to 909-962-5605 to confirm receipt of the recall notification .

    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)