Events

Recall of Microfil Composite Instruments

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Almore International 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
    76963
  • Event Risk Class
    Class 2
  • Event Number
    Z-2069-2017
  • Event Initiated Date
    2017-04-20
  • Event Date Posted
    2017-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154721
  • 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
    Carver, dental amalgam, operative - Product Code EKH
  • Reason
    Microfil composite instruments were distributed with a sterile symbol on their packaging label inserts, indicating that the products are sold as sterile devices. these products are not sterile and they are intended to be sterile prior to each use.
  • Action
    Almore International sent an urgent medical device recall letter via certified mail on April 20, 2017 to consignees informing them of the labeling error and that the device is not sterile upon receipt. On 5/8/17, the firm expanded the recall and will notify four additional consignees by 5/10/17. Almore will send new replacement label inserts to customers who still have affected device on hand upon request. Distributor should notify downstream customers and/or provides new label inserts to downstream customers as needed. Consignees should send response form to Almore International, Inc. using one of the following methods below: o Fax the completed form to 503-643-9748 or o Send the scanned form via email to info@almore.com or o Mail a copy of the completed form to: Microfil Recall, Almore International Inc. 10950 SW 5th Street, Suite 270 Beaverton, OR. 97005. If consignees have questions please contact Almore International, Inc. at 503-643-6633 Monday through Friday between 9am and 4pm PST.

Device

Microfil Composite Instruments
  • Model / Serial
    no lot codes
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distributed - US Nationwide in AZ, CA, CO, CT, FL, GA, IA, IL, IN, MA, MN, MO, NC, NJ, NV, NY, OH, PA, TN, TX, WA, and WI, and internationally in Canada, Netherlands, and South Korea.
  • Product Description
    Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a cardboard box. Microfil Composite Instruments are intended to be sterilized by the dentist prior to each use. || It is used for composite restoration development. The thin paddles shape light-cured composites. Paddles slide under the gum line to shape the margin. The flat ends contour the surfaces of the teeth and the thin edge is used to create esthetic highlights. || Models: || #96041  Gold Microfil || #96042  Green Microfil || #96043  Blue Microfil || #96044  Set of 3 Microfil (Gold, Green, Blue)
  • Manufacturer
    Almore International Inc

Manufacturer

Almore International Inc
  • Manufacturer Address
    Almore International Inc, 10950 SW 5th St Ste 270, Beaverton OR 97005-4746
  • Manufacturer Parent Company (2017)
    Almore International Inc
  • Source
    USFDA