FDA Device recall Z-1516-2016
GDC-10 360 SOFT 10MM X 20CM SR 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-10 360 SOFT 10MM X 20CM SR 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-1516-2016 |
| 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-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033471020SR0; Neurology: GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that 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: M0033471020SR0; Lot codes: 17074659, 17581672, and 18617200. |
|---|
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-1516-2016%22
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