Recall Z-1517-2016— Stryker Neurovascular

Name: FDA recall Z-1517-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-21

Class II · Terminated

Class II FDA medical device recall by Stryker Neurovascular, initiated 2016-03-21, terminated 2016-07-05. It names one FDA 510(k) clearance: K042539. Product: 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: The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils..

Recalling firm: Stryker Neurovascular
Classification: Class II
Status: Terminated
Initiated: 2016-03-21
Terminated: 2016-07-05
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K042539 — GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COILBoston Scientific Corp·cleared 2004-10-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.