Events

Recall of NX3 TryIn Gel

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical.

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
    66276
  • Event Risk Class
    Class 2
  • Event Number
    Z-2259-2013
  • Event Initiated Date
    2013-09-13
  • Event Date Posted
    2013-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121933
  • 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
    Material, tooth shade, resin - Product Code EBF
  • Reason
    Kerr corporation is voluntarily recalling one lot of nx3 try-in gel, because some of the nx3 try-in gel syringes in the affected lot contain a different product material. the material in the affected syringe does not match the shade of the cement as it is labeled.
  • Action
    Kerr Corporation initiated the voluntary recall by sending out notifications on 09/13/2013 via USPS 1st class mail. The recall notification letter, titled "URGENT: MEDICAL DEVICE RECALL", informed customer of the recall's product description, reason for recall, potential risk, instructions to customers and contact information.

Device

NX3 TryIn Gel
  • Model / Serial
    Part Number 33660. Syringe Lot Number 4580333. Autobag Lot Number 4584609.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution, including Nationwide in the US and the countries of Canada, Great Britain, Australia, France, Germany, Italy, Denmark, Hong Kong, China, Brazil and Saudi Arabia.
  • Product Description
    NX3 Try-In Gel. The product is used as a tooth shade resin material.
  • Manufacturer
    Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical

Manufacturer

Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
  • Manufacturer Address
    Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical, 1717 W Collins Ave, Orange CA 92867-5422
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA