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U.S. Department of Health and Human Services

Class 2 Device Recall GDC 360 Detachable Coil

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  Class 2 Device Recall GDC 360 Detachable Coil see related information
Date Initiated by Firm March 21, 2016
Create Date April 19, 2016
Recall Status1 Terminated 3 on July 05, 2016
Recall Number Z-1516-2016
Recall Event ID 73705
510(K)Number K042539  
Product Classification Device, neurovascular embolization - Product Code HCG
Product 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.
Code Information Model number: M0033471020SR0; Lot codes: 17074659, 17581672, and 18617200.
Recalling Firm/
Manufacturer		 Stryker Neurovascular
47900 Bayside Pkwy
Fremont CA 94538-6515
For Additional Information Contact Geraline Ahern
510-413-2593
Manufacturer Reason
for Recall		 The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.
FDA Determined
Cause 2		 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 within 7 calendar days, as well as notify any other organizations that the device may have been distributed to. Should you have any queries concerning this matter contact Quality Manager at 510-413-2593 or email: Geraldine.ahern@stryker.com
Quantity in Commerce 316 total, 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HCG and Original Applicant = BOSTON SCIENTIFIC CORP.
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