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.
Enforcement
- Recall Number
- Z-1516-2016
- Event ID
- 73705
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Stryker Neurovascular
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 27, 2016
- Initiation Date
- March 21, 2016
- Classification Date
- April 19, 2016
- Termination Date
- July 5, 2016
- Address
- 47900 Bayside Pkwy, N/A, Fremont, CA, 94538-6515, United States
Description
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.
The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.
Model number: M0033471020SR0; Lot codes: 17074659, 17581672, and 18617200.
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.
316 total, both models