FDA Enforcement
Class II
Terminated
GDC-10 360 10mm x 30cm SR ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's 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
Recall: Z-0479-2015
·
Reported December 10, 2014
Enforcement
- Recall Number
- Z-0479-2015
- Event ID
- 69669
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Stryker Neurovascular
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 10, 2014
- Initiation Date
- October 22, 2014
- Classification Date
- November 28, 2014
- Termination Date
- February 12, 2015
- Address
- 47900 Bayside Pkwy, N/A, Fremont, CA, 94538-6515, United States
Description
GDC-10 360 10mm x 30cm SR ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's 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
Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
Code Info
Model M0033461030SRO, Lot number: 13239506; Exp. Jan 2013.
Distribution
US Distribution to the states of: VA, NH, OH and TX.
Quantity
1 unit