Recall Z-2069-2017 ยท EKH Carver, Dental Amalgam, Operative
Almore International Inc
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
| Date | May 10, 2017 (initiated Apr 20, 2017) |
| Status | Terminated |
| 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. |
| Root cause | 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. us |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.