Events

Recall of Device Recall Heraeus Kulzer GLUMA Comfort Bond Desensitizer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Heraeus Kulzer Inc., Dental Products Division.

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
    44827
  • Event Risk Class
    Class 3
  • Event Number
    Z-0035-2008
  • Event Initiated Date
    2007-07-09
  • Event Date Posted
    2007-10-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64418
  • 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
    dental bonding agent - Product Code KLE
  • Reason
    The material may solidify in the bottle, and thus be rendered unusable.
  • Action
    Consignees were notified via phone or undated letter sent via fax beginning on or about 7/9/07 and instructed to contact the firm for return authorization/instructions.

Device

Device Recall Heraeus Kulzer GLUMA Comfort Bond Desensitizer
  • Model / Serial
    Lot 010065; exp. 02/2009.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
  • Manufacturer
    Heraeus Kulzer Inc., Dental Products Division

Manufacturer

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