Events

Recall of K3 Engine File GPack

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

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
    61224
  • Event Risk Class
    Class 3
  • Event Number
    Z-1172-2012
  • Event Initiated Date
    2008-08-01
  • Event Date Posted
    2012-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107604
  • 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
    File, pulp canal, endodontic - Product Code EKS
  • Reason
    A recall was initiated because sybronendo has confirmed that the k3 engine file g-pack has label packaging and file mis-marking error.
  • Action
    A recall communication was initiated on 07/31/2008 with SybronEndo forwarding an Urgent Medical Device Recall letter (via USPS 1st class mail) to all their customers who purchased the K3 Engine File G-Pack (Part No. 830-9925). The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to contact SybronEndo Customer Care at (800) 346-3636 directly to handle the arrangements of a quick return and replacement. Customers were instructed to complete the Return Form and return any affected product in their inventory.

Device

K3 Engine File GPack
  • Model / Serial
    Lot Number: 08E182E.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including the territory of St. Thomas, and countries of Australia, Canada, New Zealand, China, Singapore, India, and Chile.
  • Product Description
    K3 Engine File G-Pack, || Product: Endodontic Pulp Canal File, Part Number: 830-9925. || For use in root canal preparation.
  • Manufacturer
    Ormco Corporation

Manufacturer

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