Events

Recall of Device Recall Elements Obturation Unit

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
    78861
  • Event Risk Class
    Class 2
  • Event Number
    Z-0413-2018
  • Event Initiated Date
    2017-12-27
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160754
  • 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
    Plugger, root canal, endodontic - Product Code EKR
  • Reason
    Buchanan heat pluggers will possibly overheat while used with the elements obturation unit (eou).
  • Action
    Sybron Endo sent an Urgent: Medical Device Recall letter dated December 27, 2017. Customers were informed that Sybron Endo was still evaluating the root cause and would provide additional instructions once the root cause is determined. Distributors were asked to cease distributing any Elements Obturation Units (EOU), confirm if any are in inventory, return any affected devices, provide the notification to customers if further distributed, return any affected devices received from customers, and complete and return the acknowledgement form. Customers were instructed to examine current inventory for affected product, check the heat plugger to see if the NiTi icon appears and/or the tip turns glowing red, if it does do not use the heat plugger and return it to Sybron Endo, and complete and return the acknowledgement form. For further questions, please call the Customer Care department at (800) 537-7123.

Device

Device Recall Elements Obturation Unit
  • Model / Serial
    Part Number for Elements Obturation Unit (EOU): 973-0322; and Part Numbers for the Buchanan Heat Pluggers: 952-0004, 952-0003, 952-0005, 952-0006, 952-0007, 952-0031, 973-0219 (hot pulp test tip). All serial numbers of the EOU and respective Buchanan Heat Pluggers are included in the recall.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA (nationwide) distributed to AK, AL, AR, AZ, CA, CO, 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed internationally to Armenia, Australia, Canada, Chile, Ecuador, El Salvador, Guatemala, Hong Kong, India, Japan, Malaysia, Mexico, Netherlands, Pakistan, Panama, Philippines, Singapore, South Korea, Switzerland, Thailand, United Kingdom, Vietnam.
  • Product Description
    Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers || Device is an endodontic root canal plugger. It is intended to be used in Dentistry to provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, to backfill and downpack gutta percha during Endodontic root canal treatment, and when in Extruder mode it is used only to backfill gutta percha during root canal obturation.
  • 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