[Recalled] 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
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| 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 |
|---|---|
| Brand / manufacturer | Stryker Neurovascular |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1516-2016 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 21 March 2016 |
| EAN / barcode | 17074659 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Stryker Neurovascular
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.