Device recall
Z-0480-2015: GDC-18 360 20mm x 33cm; GDC 360 Detachable Coils are intended for embolization…
FDA device recall · Class II · Stryker Neurovascular
Key facts
| Recall number (Z-number) | Z-0480-2015 |
|---|---|
| Recall event | 69669 |
| Product | GDC-18 360 20mm x 33cm ; 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 by… |
| 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