FDA Device recall Z-1517-2016
GDC-18 360 11MM X 30CM Detachable Coil Sterile
- FDA Device
- Class II
- terminated
- Published 2016-04-27
On 2016-04-27 the FDA classified a Class II recall of GDC-18 360 11MM X 30CM Detachable Coil Sterile by Stryker Neurovascular, citing the incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1517-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-21 |
| Published | 2016-04-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Neurovascular |
| Distribution | US |
Product
GDC-18 360 11MM X 30CM Detachable Coil Sterile; Model number: M0033471020SR0 Neurology: GDC 360 degree Detachable Coils are intended for embolization of those intracranial aneurysms that¿a because of their morphology, their location, or the patients general medical condition are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable.
Reason
The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.
Identifiers
| code_info | Model Number: GDC-18 360 11MM X 30CM; Lot numbers: 17723781, 17735100 and 17818842. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1517-2016%22
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