Device recall
Z-1695-2018: Straumann Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article…
FDA device recall · Class II · Straumann Manufacturing, Inc.
Key facts
| Recall number (Z-number) | Z-1695-2018 |
|---|---|
| Recall event | 79738 |
| Product | Straumann Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.113 |
| Product code | NQA |
| Recalling firm | Straumann Manufacturing, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 2, 2019 |
| PMA numbers | P930021 |
| FEI number | 1000121052 |
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