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U.S. Department of Health and Human Services

Class 2 Device Recall Microfil Composite Instruments

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  Class 2 Device Recall Microfil Composite Instruments see related information
Date Initiated by Firm April 20, 2017
Date Posted May 10, 2017
Recall Status1 Terminated 3 on August 22, 2017
Recall Number Z-2069-2017
Recall Event ID 76963
Product Classification Carver, dental amalgam, operative - Product Code EKH
Product 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)
Code Information no lot codes
Recalling Firm/
Manufacturer		 Almore International Inc
10950 SW 5th St Ste 270
Beaverton OR 97005-4746
For Additional Information Contact
503-643-6633
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Employee error
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.
Quantity in Commerce 1773 devices (US =1570; International = 203)
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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