FDA Device recall Z-2069-2017
Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a cardboard box
- FDA Device
- Class II
- terminated
- Published 2017-05-17
On 2017-05-17 the FDA classified a Class II recall of Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a cardboard box by Almore International, citing 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 ar….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2069-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-20 |
| Published | 2017-05-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Almore International |
| Distribution | US |
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
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.
Identifiers
| code_info | no lot codes |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2069-2017%22
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