Events

Recall of Device Recall SybronEndo Replacement AC Power Cord, US Elements Obturation;

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
    64216
  • Event Risk Class
    Class 2
  • Event Number
    Z-1545-2013
  • Event Initiated Date
    2013-01-17
  • Event Date Posted
    2013-06-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115619
  • 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
    A recall has been issued by sybronendo because a canadian standards association (csa)-directed cautionary statement label was inadvertently omitted from the elements obturation unit and its replacement a/c power cord.
  • Action
    The firm SybronEndo sent a "FIELD CORRECTION ACTION" letter dated January 30, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were requested to review and determine if they have any of the affected equipment in their inventory; Note: the equipment itself has not been modified in any way, and therefore there is no change in the performance; customers should continue to use the equipment in the same manner they have in the past:; Note: SynbronEndo has enclosed the cautionary label along with instructions for proper placement of the affected equipment; the customers should apply the enclosed cautionary statement label to Elements Obturation Unit and/or Replacement AC Power Cord as per instructions and complete and return the FIELD CORRECTION ACKNOWLEDGEMENT FORM ,whether or not they have any affected equipment in their inventory, via Fax to: 909-962-5605. For questions regarding this recall call 714-516-7602. Note: If you are an authorized SybronEndo international distributor, we request that you identify those customers that may have been shipped the affected lots of equipment and contact these customers to inform them of the issue within forty-eight (48) hours of receipt of this notification. If you have any questions, contact SybronEndo Customer Care at 1-800-346-3636.

Device

Device Recall SybronEndo Replacement AC Power Cord, US Elements Obturation;
  • Model / Serial
    Lot/Serial Numbers: 3757349, 4220920, 4304917, 4367699, 436513, 4445719, 4458262, 4522605, 4581118, 4724407, 4730212
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Azerbaijan, Belgium, Canada, China, Cyprus, Czech Republic, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Italy, Japan, Kuwait, Latvia, Lebanon, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Romania, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, and United Kingdom.
  • Product Description
    SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy, Made in Taiwan || The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic 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