Device recall
Z-1121-2017: Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar…
FDA device recall · Class II · Medtronic Neurosurgery
Key facts
| Recall number (Z-number) | Z-1121-2017 |
|---|---|
| Recall event | 76249 |
| Product | Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve is a shunt component designed to allow for continuous flow of cerebrospinal fluid (CSF) from the… |
| Product code | JXG |
| Recalling firm | Medtronic Neurosurgery |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 2, 2017 |
| 510(k) numbers | K033850, K042465, K060681, K082127 |
| 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