Events

Recall of Device Recall Septodont aka Novocol

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

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
    68794
  • Event Risk Class
    Class 2
  • Event Number
    Z-2128-2014
  • Event Initiated Date
    2014-07-16
  • Event Date Posted
    2014-07-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128750
  • 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
    Agent tooth bonding, resin - Product Code KLE
  • Reason
    Septodont is recalling self-etch bond because the material was incorrectly packaged.
  • Action
    An email was sent on 7/16/14 to the two distributors requesting the return of all units of Lot C4211-3 in stock.

Device

Device Recall Septodont aka Novocol
  • Model / Serial
    Product Order Number 112-6966; Lot Number C4211-3; UPC Code *+H65811269662O*; Expiration Date September 2015.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was sent to two wholsalers/distributors in PA and NY. No product was distributed outside of the US or to government/VA consignees.
  • Product Description
    Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure || Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.
  • Manufacturer
    Novocol, Inc.

Manufacturer

Novocol, Inc.
  • Manufacturer Address
    Novocol, Inc., 416 S Taylor Ave, Louisville CO 80027-3028
  • Manufacturer Parent Company (2017)
    Novocol Inc.
  • Source
    USFDA