Z-2069-2017Class II

Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a...

Name: Z-2069-2017 Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a...
Creator: Almore International Inc
Published: 2017-04-20
License: https://open.fda.gov/license/

Almore International Inc / initiated 2017-04-20 / Terminated / root cause: manufacturing process

FDA source

Almore International Inc began a recall of Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a cardboard box. Microfil Composite Instruments are intended... on 2017-04-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2069-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-20
Posted: 2017-05-10
Terminated: 2017-08-22
Recalling firm: Almore International Inc
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)
Product code: EKH Carver, Dental Amalgam, Operative
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.
Root cause tag: manufacturing process
FDA 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. 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.
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.
Product codes and lots: no lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2069-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2069-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-10

Product code EKH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)