Device recall
Z-1116-2021: Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves…
FDA device recall · Class II · Medtronic Neurosurgery
Key facts
| Recall number (Z-number) | Z-1116-2021 |
|---|---|
| Recall event | 87157 |
| Product | Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM, 27740 - SHUNT 27740 STRATA NSC SNAP REG 120CM, 27812 - VALVE 27812 STRATA II SM EXTRACTED, 27814 - SHUNT 27814 STRATA II ASSY SML, 27815… |
| Product code | JXG |
| Recalling firm | Medtronic Neurosurgery |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K033850, K042465, K060681, K083076, K123524 |
| 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