Events

Recall of NX3 TRY - IN GEL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by KERR CORPORATION.

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
    17648
  • Event Risk Class
    II
  • Event Initiated Date
    2013-09-13
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    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. there is a risk that use of the affected material to evaluate shade prior to cementation may result in an unanticipated final restoration color requiring the need to remove and repeat the restoration.

Device

NX3 TRY - IN GEL
  • Model / Serial
    Model Catalog: 33660 (Lot serial: syringe lot# 4580333); Model Catalog: 33660 (Lot serial: autobag lot# 4584609)
  • Product Description
    NX3 Try-In Gel
  • Manufacturer
    KERR CORPORATION

Manufacturer

KERR CORPORATION