Class 2 Device Recall Target Detachable Coils

• Date Initiated by Firm: June 06, 2016
• Date Posted: July 11, 2016
• Recall Status: Terminated on March 03, 2017
• Recall Number: Z-2175-2016
• Recall Event ID: 74425
• 510(K)Number: K113412 K153658
• Product Classification: Device, neurovascular embolization - Product Code HCG
• Product: Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040 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:M0035443040 : Lot Number/Expiration Date: 18442838 30-Jun-18 18442388 30-Jun-18 18490600 31-Jul-18 18831276 31-Jan-19 18760116 31-Dec-18 18760119 31-Dec-18 18584035 30-Sep-18 18470827 31-Jul-18 18442358 30-Jun-18 18830247 31-Jan-19 18470767 30-Jun-18 18470857 31-Jul-18 18800019 31-Jan-19 18760117 31-Dec-18 18568317 31-Aug-18 18462748 30-Jun-18 18443108 30-Jun-18 18442178 30-Jun-18 18568224 31-Aug-18 18490538 31-Jul-18 18462838 30-Jun-18 18568193 31-Aug-18 18584004 30-Sep-18 18490662 31-Jul-18 18442688 30-Jun-18 19066241 31-May-19 19035290 31-May-19 18902944 28-Feb-19 18877825 28-Feb-19 18973721 30-Apr-19 18846664 31-Jan-19 19081717 31-May-19 19026562 30-Apr-19 18973029 30-Apr-19 18876957 28-Feb-19 18905865 28-Feb-19 19027086 30-Apr-19 19080897 31-May-19 19063669 31-May-19 18845906 31-Jan-19 18845527 31-Jan-19 19026038 30-Apr-19 18902302 28-Feb-19 18846285 31-Jan-19 19081102 31-May-19 18901660 28-Feb-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: 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