Events

Recall of Premisa

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kerr Corp.

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
    49506
  • Event Risk Class
    Class 2
  • Event Number
    Z-0258-2009
  • Event Initiated Date
    2008-09-05
  • Event Date Posted
    2008-11-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74638
  • 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 composite - Product Code EBF
  • Reason
    Material stiff: material in several lots of premise unidose appears to stiffen and become difficult to extrude over time.
  • Action
    Kerr sent an Urgent Medical Device Recall letter to consignees via USPS first class mail the week of September 8, 2008, requesting they return the product for replacement or credit. The recall notification requested the return of the affected products because the material appears to stiffen and become difficult to extrude over time. Customers were instructed if they have any of the affected lots of product in their inventory to immediately return it to Kerr. Any product returned will be replaced at no charge or credited to your account. In addition, customers were instructed to fax the attached Recall Return Form to 714-516-7739. If the customers were an authorized Kerr distributor, they were requested to identify and recover the affected product lots listed on the attached Lot Number Table that may have been shipped to their customers. Also, customers were instructed to contact Kerr Customer Care at 1 -800-537-7123 directly to handle the arrangements of a quick return and replacement

Device

Premisa
  • Model / Serial
    LOT NUMBER(S): 3001318, and 3018916
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: USA, Australia, Canada, Hong Kong, Malaysia, Mexico, and Singapore.
  • Product Description
    PREMISE, PART NO. 32812, 10 PACK UNIDOSE PREMISA A2 (INTERNATIONAL ONLY), dental composite
  • Manufacturer
    Kerr Corp

Manufacturer

Kerr Corp
  • Manufacturer Address
    Kerr Corp, 1717 W Collins Ave, Orange CA 92867-5422
  • Source
    USFDA