FDAMarch 21, 2016device
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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.
What to do
FDA enforcement status: Terminated
Brands named
stryker neurovascularstryker
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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