Device recall
Z-0479-2015: GDC-10 360 10mm x 30cm SR; GDC 360 Detachable Coils are intended for…
FDA device recall · Class II · Stryker Neurovascular
Key facts
| Recall number (Z-number) | Z-0479-2015 |
|---|---|
| Recall event | 69669 |
| Product | GDC-10 360 10mm x 30cm SR ; GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management… |
| Product code | HCG |
| Recalling firm | Stryker Neurovascular |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 12, 2015 |
| 510(k) numbers | K103355 |
| FEI number | 3008853977 |
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