Events

Recall of Device Recall TF Adaptive Gutta Percha Point Size SM3 50pk

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ormco/Sybronendo.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73293
  • Event Risk Class
    Class 2
  • Event Number
    Z-1083-2016
  • Event Initiated Date
    2016-02-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143777
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Gutta-percha - Product Code EKM
  • 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 .

Device

Device Recall TF Adaptive Gutta Percha Point Size SM3 50pk
  • Model / Serial
    GE15011637
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Mexico, Europe, Hong Kong, MY, IN, JP, ID, SG, TH
  • Product Description
    TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 || Intended to fill a endontontically obturated root canal treatment
  • Manufacturer
    Ormco/Sybronendo

Manufacturer

Ormco/Sybronendo
  • Manufacturer Address
    Ormco/Sybronendo, 1332 S Lone Hill Ave, Glendora CA 91740-5339
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA