BEUDAMED
    FDA Enforcement Class II Terminated

    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)

    Recall: Z-2069-2017 · Reported May 17, 2017

    Enforcement

    Recall Number
    Z-2069-2017
    Event ID
    76963
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Almore International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 17, 2017
    Initiation Date
    April 20, 2017
    Classification Date
    May 10, 2017
    Termination Date
    August 22, 2017
    Address
    10950 SW 5th St Ste 270, N/A, Beaverton, OR, 97005-4746, United States

    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)

    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.

    Code Info

    no lot codes

    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.

    Quantity

    1773 devices (US =1570; International = 203)