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Stryker Neurovascular recalls GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033471020SR0; Neurology: GDC 360 Detachable
Recalled April 27, 2016 · FDA recall Z-1516-2016 · Stryker Neurovascular
Hazard
The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils. · FDA Class II
Units
316 total, both models
Sold at
Worldwide Distribution: US (nationwide) including states of: OH, CO, WA, IL, MI, CA, TX and countries of: Hong Kong, Italy, Germany, France, Spain, Australia, Canada, Sweden, India, Turkey, Cyprus, Belgium, Switzerland, Czech Republic, Uruguay, Mexico, Saudi Arabia, Russia, Brazil, Netherlands, and Ukraine.
Description
The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.
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.
Manufacturer(s)
Stryker Neurovascular
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →