Device recall
Z-2069-2017: Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which…
FDA device recall · Class II · Almore International Inc
Key facts
| Recall number (Z-number) | Z-2069-2017 |
|---|---|
| Recall event | 76963 |
| 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… |
| Product code | EKH |
| Recalling firm | Almore International Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 22, 2017 |
| FEI number | 3018986 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database