Events

Recall of PEPGEN P-15 PUTTY

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

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
    139199
  • Event Risk Class
    II
  • Event Initiated Date
    2005-03-16
  • 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
    External packaging of lot 04p1017a was mislabeled. incorect expiration date was placed on the external label indicating a three-year rather than one year expiration date.

Device

PEPGEN P-15 PUTTY
  • Model / Serial
    Model Catalog: 99U200-005 (Lot serial: 04p1017a lot number); Model Catalog: 99U200-005 (Lot serial: 99U200-005 dev. identifier)
  • Product Description
    PepGen P-15 Putty
  • Manufacturer
    DENTSPLY CANADA LTD.

Manufacturer

DENTSPLY CANADA LTD.