Device recall
Z-0809-2018: proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System…
FDA device recall · Class II · Aesculap Implant Systems LLC
Key facts
| Recall number (Z-number) | Z-0809-2018 |
|---|---|
| Recall event | 79093 |
| Product | proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System Shunt, central nervous system and components |
| Product code | JXG |
| Recalling firm | Aesculap Implant Systems LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 8, 2018 |
| 510(k) numbers | K161853 |
| FEI number | 2916714 |
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