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.
Reported: April 27, 2016 Initiated: March 21, 2016 #Z-1517-2016
Product Description
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 for Recall
The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.
Details
- Recalling Firm
- Stryker Neurovascular
- Units Affected
- 316 devices, both models
- Distribution
- 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.
- Location
- Fremont, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Stryker Neurovascular. Units affected: 316 devices, both models.
Why was this product recalled? ▼
The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 27, 2016. Severity: Moderate. Recall number: Z-1517-2016.
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