Events

Recall of Heraeus Kulzer brand P2 Magnum 360 Monophase 3X (2x360); catalog number 66009584.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Heraeus Kulzer 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
    29993
  • Event Risk Class
    Class 3
  • Event Number
    Z-0626-05
  • Event Initiated Date
    2003-11-01
  • Event Date Posted
    2005-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-04-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34940
  • 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, Impression - Product Code ELW
  • Reason
    Packaging defects could result in improper mixing ratios and unusable impressions.
  • Action
    Customers were notified via undated letter on or about November 1, 2003 and instructed to return product on hand..

Device

Heraeus Kulzer brand P2 Magnum 360 Monophase 3X (2x360); catalog number 66009584.
  • Model / Serial
    Lot 190416.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Heraeus Kulzer brand P2 Magnum 360 Monophase 3X (2x360); catalog number 66009584.
  • Manufacturer
    Heraeus Kulzer Inc.

Manufacturer

Heraeus Kulzer Inc.
  • Manufacturer Address
    Heraeus Kulzer Inc., 4315 S Lafayette Blvd, South Bend IN 46614-2517
  • Source
    USFDA