Device recall
Z-1019-2017: OPT Croutons is a synthetic bone substitute designed for the repair of bony…
FDA device recall · Class II · Acumed LLC
Key facts
| Recall number (Z-number) | Z-1019-2017 |
|---|---|
| Recall event | 75904 |
| Product | OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt. |
| Product code | MQV |
| Recalling firm | Acumed LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 22, 2017 |
| 510(k) numbers | K042340 |
| FEI number | 1000125930 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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