Device recall
Z-0877-2015: Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used…
FDA device recall · Class II · PEROUSE MEDICAL
Key facts
| Recall number (Z-number) | Z-0877-2015 |
|---|---|
| Recall event | 69879 |
| Product | Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheter |
| Product code | MAV |
| Recalling firm | PEROUSE MEDICAL |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 24, 2017 |
| 510(k) numbers | K110604 |
| FEI number | 3006942524 |
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