Device recall
Z-0399-2014: Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata II…
FDA device recall · Class II · Medtronic Neurosurgery
Key facts
| Recall number (Z-number) | Z-0399-2014 |
|---|---|
| Recall event | 66882 |
| Product | Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata II Shunt Assemblies are designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart of the peritoneal cavity. |
| Product code | JXG |
| Recalling firm | Medtronic Neurosurgery |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 6, 2014 |
| 510(k) numbers | K042465 |
| FEI number | 3015531529 |
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