Device recall
Z-0535-2014: 3M ESPE Imprint II Regular Body, Catalog Number 9379, and Paradigm Regular Body…
FDA device recall · Class II · 3M Company - Health Care Business
Key facts
| Recall number (Z-number) | Z-0535-2014 |
|---|---|
| Recall event | 66944 |
| Product | 3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce the structure of a patients teeth. Impression Materials are composed of hydrophilic vinyl polysiloxane impression materials, designed for… |
| Product code | ELW |
| Recalling firm | 3M Company - Health Care Business |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 2, 2014 |
| 510(k) numbers | K000591 |
| FEI number | 2110898 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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