Events

Recall of Device Recall Maxcem Elite, a dental cement

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    60685
  • Event Risk Class
    Class 2
  • Event Number
    Z-0915-2012
  • Event Initiated Date
    2011-02-03
  • Event Date Posted
    2012-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106203
  • 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 cement w/out zinc-oxide eugenol as an ulcer covering for pain relief - Product Code MZW
  • Reason
    The recall was initiated because kerr corporation has confirmed that the use of the affected lot of maxcem elite may not provide users with a minimum of 2 minutes of work¿time thereby causing the product to prematurely set by 15 seconds.
  • Action
    Kerr Corporation sent a Urgent Medical Device Recall letter dated March 14, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It has recently come to our attention that use of the affected lot of product may not provide users with a minimum of 2 minutes of work¿time thereby causing the product to prematurely set by 15 seconds. If this were to happen prior to placing restorations on the tooth or core build-up the restorations may not adhere properly. If you have any of the affected product listed above please contact Kerr Customer Care at 1-800-537-7123 to receive an RMA number. The RMA will allow for a quick return and replacement or credit. Please fax back the enclosed Recall Return Form in order to confirm your receipt of this recall notification regardless of whether you have any product in your inventory.

Device

Device Recall Maxcem Elite, a dental cement
  • Model / Serial
    Lot Number 3360900
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and the countries of Canada, Australia and New Zealand.
  • Product Description
    Brand name: Maxcem Elite, || Product: a dental cement, || Part Number: 34418. || The intended use of this device is for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bridges, posts and veneers. Additional Indications include core-buildup material, pit and fissure sealant and cementation of crown restorations to implants
  • Manufacturer
    Kerr Corporation

Manufacturer

Kerr Corporation
  • Manufacturer Address
    Kerr Corporation, 1717 W Collins Ave, Orange CA 92867-5422
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA