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)

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.

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 [email protected] 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.