Microfil Composite Instruments are packaged in an unsealed plastic… — Class II medical device recall Z-2069-2017
Terminated recall by Almore International Inc, reported 2017-05-17, distributed nationwide. Microfil Composite Instruments were distributed with a sterile symbol on their packaging label inserts, indica
| Recall number | Z-2069-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Almore International Inc, Beaverton, OR, United States |
| Recall initiated | 2017-04-20 |
| Classified | 2017-05-10 |
| Reported by FDA | 2017-05-17 |
| Terminated | 2017-08-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, KR, NL |
| Reason classes | labeling, sterility |
| Model numbers | 96041 |
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)
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2069-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.