Device recall
Z-1297-2016: Extreme Custom Product Usage: Extreme Custom is an external knee braces to…
FDA device recall · Class II · Ossur H / F
Key facts
| Recall number (Z-number) | Z-1297-2016 |
|---|---|
| Recall event | 73380 |
| Product | Extreme Custom Product Usage: Extreme Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis. |
| Product code | IQI |
| Recalling firm | Ossur H / F |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 15, 2016 |
| FEI number | 3003764610 |
At a glance
- None Linked 510(k)s
- 10–99 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