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-2168-2016
• Recall Event ID: 74425
• 510(K)Number: K113412 K153658
• Product Classification: Device, neurovascular embolization - Product Code HCG
• Product: Target Detachable Coils:; TARGET HELICAL NANO 1.5 MM X 1 CM; MODEL Number:M0035431510; ; 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: M0035431510; Lot Number/Expiration Date: 18581295 30-Sep-18 18800256 31-Jan-19 18775373 31-Dec-18 18744204 30-Nov-18 18812788 31-Jan-19 18607578 30-Sep-18 18602655 30-Sep-18 19003141 30-Apr-19 18935435 31-Mar-19 18923481 31-Mar-19 18953907 31-Mar-19 18883412 28-Feb-19 18852906 28-Feb-19 19056331 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: 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