Events

Recall of Device Recall Breeze SelfAdhesive Resin Cement

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
    60242
  • Event Risk Class
    Class 2
  • Event Number
    Z-0186-2012
  • Event Initiated Date
    2011-07-08
  • Event Date Posted
    2011-11-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104859
  • 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
    Cement, dental - Product Code EMA
  • Reason
    Pentron is voluntarily recalling the breeze self adhesive resin cement because it was discovered that there may be a curing problem that may cause cemented crowns to fall off after use of the product.
  • Action
    Pentron Clinical sent an "Urgent: Medical Device Recall" letter dated July 18, 2011 with an attached Recall Return Form (via USPS First Clas mail) to all affected customers. The letter identified the affected product, explanation of the problem, and actions to be taken. Customers were instructed to discontinue use and return any affected product in their inventory. The letter asks that each customer complete and return the enclosed Recall Return Form via fax to 714-288-4609, in order to confirm receipt of the customer notification. Customers were instructed to contact Pentron Clinical Customer service at (800) 551-0283 (option 1) directly to handle the arrangements of a quick return and replacement.

Device

Device Recall Breeze SelfAdhesive Resin Cement
  • Model / Serial
    Syringe Lot Number: 3558203 Kit Lot Numbers: 3581367, 3564511, 3538478
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Canada, Cypress, Greece, Germany, Italy, Jordon, Poland, Romania, Turkey and Vietnam.
  • Product Description
    Breeze Self-Adhesive Resin Cement, Part Number: N97A, || Product Usage: The intended use of this device is for cementation of porcelain, resin, and metalbased inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations.
  • 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
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA