Events

Recall of Device Recall Sealapex Xpress

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
    75114
  • Event Risk Class
    Class 2
  • Event Number
    Z-2836-2016
  • Event Initiated Date
    2016-08-31
  • Event Date Posted
    2016-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149382
  • 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
    Resin, root canal filling - Product Code KIF
  • Reason
    Sybronendo is recalling the sealapex xpress because it was labeled with an incorrect expiration date of 2017-11 while the syringe was labeled with the correct expiration date of 2016-11.
  • Action
    The firm, Kerr, sent an "Urgent: Medical Device Recall" letter dated 8/31/16 to its customers. The letter describes the product, problem and actions to be taken. The customer were instructed to contact SybronEndo Customer Care at (800) 537-7123 to receive a RMA number if they have any of the affected product; and to complete and email back the enclosed acknowledgement form to Sealapex.Response@kerrdental.com , even if they do not have any of the affected product. If you have any questions, call 714-516-7802 or email to: mark.dzendzel@syndrondental.com.

Device

Device Recall Sealapex Xpress
  • Model / Serial
    lot # 5-1310
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Mexico, Belgium, Denmark, Germany, Great Britain, and Sweden.
  • Product Description
    Sealapex Xpress, Part No. 33639 || The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of a tooth.
  • 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