Recall Z-1517-2016 ยท HCG Device, Neurovascular Embolization
Stryker Neurovascular
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 thata 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 technique
| Date | Mar 21, 2016 |
| Status | Terminated |
| Reason | The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils. |
| Root cause | Under Investigation by firm |
| Action | The firm, Stryker Neurovascular, sent an "URGENT: Field Safety Notification" dated 3/21/2016 via courier to its consignees/customers. The notification describes the product, problem and actions to be taken. The customers were instructed to immediately check your inventory; follow the instructions listed in the Directions For Use (DFU); circulate and maintain the notice internally to all interested/affected parties; inform Stryker if any of the subject devices have been distributed; complete and return the FIELD SAFETY CORRECTIVE ACTION AKNOWLEDGMENT FORM to Stryker via fax at 1 (866) 876-4355 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042539 | GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL Boston Scientific Corp, Oct 19, 2004 |