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U.S. Department of Health and Human Services

Class 2 Device Recall Target Detachable Coils

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  Class 2 Device Recall Target Detachable Coils see related information
Date Initiated by Firm June 06, 2016
Date Posted July 11, 2016
Recall Status1 Terminated 3 on March 03, 2017
Recall Number Z-2179-2016
Recall Event ID 74425
510(K)Number K113412  K153658  
Product Classification Device, neurovascular embolization - Product Code HCG
Product Target Detachable Coils:
TARGET HELICAL NANO 2MM X 3CM
MODEL Number:M0035452030




Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Code Information MODEL Number::M0035452030;  Lot Number/Expiration Date: 19032837 30-Apr-19 19034203 31-May-19 18953644 31-Mar-19 19032930 30-Apr-19 18986505 30-Apr-19 18922370 31-Mar-19 18987445 30-Apr-19 18972051 30-Apr-19 18971500 30-Apr-19 18905990 31-Mar-19 19060369 31-May-19.  
Recalling Firm/
Manufacturer
Stryker Neurovascular
47900 Bayside Pkwy
Fremont CA 94538-6515
For Additional Information Contact Geraldin Ahern
510-413-2593
Manufacturer Reason
for Recall
Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.
FDA Determined
Cause 2
Process change control
Action Stryker Neurovascular sent an Urgent Medical Device Voluntary Recall letter dated June 3, 2016, to all affected customers via FED Ex. Letter includes recall letter, list of impacted lot numbers, customer acknowledgement form and frequently asked questions. Customers were instructed to immediately check their inventory. segregate the effected inventory in a secure location for return to Stryker, circulate the Field Safety Notice internally to all interested/affected parties. Inform Stryker if any of the subject devices have been distributed to other organizations. Customers were also instructed to complete the attached customer response form and return the completed form to their nominated Stryker Representative.
Quantity in Commerce 45,302 (8,188 in the U.S.) - total, all model numbers
Distribution Worldwide Distribution - US (nationwide) and Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italia, Japan,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Mexico,Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, and Vietnam.
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 = STRYKER NEUROVASCULAR
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