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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-2162-2016
Recall Event ID 74425
510(K)Number K113412  K153658  
Product Classification Device, neurovascular embolization - Product Code HCG
Product Target Detachable Coils:
TARGET 360 NANO 1.5 MM X 2 CM
MODEL Number: M0035421520

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: M0035421520: Lot Number/Expiration Date: 18571775 31-Aug-18 18826432 31-Jan-19 18820709 31-Jan-19 18810506 31-Jan-19 18771506 31-Dec-18 18742834 31-Dec-18 18641914 31-Oct-18 18660947 31-Oct-18 18432978 30-Jun-18 18825388 31-Jan-19 18810970 31-Jan-19 18820593 31-Jan-19 18758780 31-Dec-18 18789731 31-Jan-19 18742776 31-Dec-18 18721938 30-Nov-18 18676533 30-Nov-18 18633805 31-Oct-18 18641972 31-Oct-18 18825910 31-Jan-19 18826258 31-Jan-19 18701086 30-Nov-18 18742718 31-Dec-18 18676359 30-Nov-18 18700796 30-Nov-18 18666663 31-Oct-18 18625251 31-Oct-18 18642030 31-Oct-18 18598415 30-Sep-18 18534255 31-Aug-18 18821173 28-Feb-19 18810390 31-Jan-19 18789847 31-Jan-19 18789673 31-Jan-19 18758370 31-Dec-18 18728186 30-Nov-18 18700680 30-Nov-18 18625135 30-Sep-18 18576927 30-Sep-18 18534545 31-Aug-18 18487470 31-Jul-18 18460621 30-Jun-18 18826084 31-Jan-19 18825736 31-Jan-19 18825562 31-Jan-19 18810738 31-Jan-19 18820941 31-Jan-19 18820825 31-Jan-19 18778633 31-Dec-18 18742950 31-Dec-18 18714130 30-Nov-18 18666489 31-Oct-18 18625193 30-Sep-18 18629461 31-Oct-18 18590180 30-Sep-18 18562973 31-Aug-18 18534023 31-Aug-18 18563089 31-Aug-18 18406635 31-May-18 18642088 31-Oct-18 18810622 31-Jan-19 18778428 31-Dec-18 18789963 31-Jan-19 18771622 31-Dec-18 18722727 30-Nov-18 18701028 30-Nov-18 18648913 31-Oct-18 18666547 31-Oct-18 18590354 30-Sep-18 18563263 31-Aug-18 18821057 31-Jan-19 18771042 31-Dec-18 18742660 31-Dec-18 18700970 30-Nov-18 18660831 31-Oct-18 18563321 31-Aug-18 18582739 30-Sep-18 18559308 31-Aug-18 18482415 30-Jun-18 18439457 30-Jun-18 18789905 31-Jan-19 18810854 31-Jan-19 18820477 31-Jan-19 18789789 31-Jan-19 18758575 31-Dec-18 18742892 30-Nov-18 18700912 30-Nov-18 18700622 30-Nov-18 18660889 31-Oct-18 18642146 31-Oct-18 18641856 31-Oct-18 18563147 31-Aug-18 18439343 30-Jun-18 18397945 31-May-18 19055171 31-May-19 19028965 30-Apr-19 19028733 30-Apr-19 18991622 30-Apr-19 19070054 31-May-19 19069822 31-May-19 19014397 30-Apr-19 18948006 31-Mar-19 18977668 30-Apr-19 18934071 31-Mar-19 18933781 31-Mar-19 18896026 28-Feb-19 18870593 28-Feb-19 18870941 28-Feb-19 18848567 31-Jan-19 19055055 31-May-19 18979060 30-Apr-19 18871174 28-Feb-19 18882282 28-Feb-19 18934013 31-Mar-19 18933955 31-Mar-19 18870712 28-Feb-19 18870833 28-Feb-19 18848451 28-Feb-19 18991796 30-Apr-19 19075803 31-May-19 18947658 31-Mar-19 18933897 31-Mar-19 18914143 31-Mar-19 18913354 28-Feb-19 18870480 28-Feb-19 18881934 28-Feb-19 18848277 31-Jan-19 19055519 31-May-19 19055403 31-May-19 19054939 31-May-19 19070518 31-May-19 19014455 30-Apr-19 18947136 31-Mar-19 18934129 31-Mar-19 18882166 28-Feb-19 19029197 30-Apr-19 19029661 30-Apr-19 19043814 31-May-19 19043547 31-May-19 19070750 31-May-19 19070286 31-May-19 19014165 30-Apr-19 19014513 30-Apr-19 19014223 30-Apr-19 18963440 31-Mar-19 18977900 30-Apr-19 18954755 31-Mar-19 18933839 31-Mar-19 18895736 28-Feb-19 18848509 31-Jan-19 18914406 31-Mar-19 18871055 28-Feb-19 19043725 31-May-19 19014281 30-Apr-19 19014339 30-Apr-19 18964832 31-Mar-19 18978364 30-Apr-19 18913880 31-Mar-19 18882398 28-Feb-19 18882050 28-Feb-19 18882514 28-Feb-19 18848335 31-Jan-19 19055635 31-May-19 19001678 30-Apr-19 18963904 31-Mar-19 18978596 30-Apr-19 18978132 30-Apr-19 18955661 31-Mar-19 18947832 31-Mar-19 18947310 31-Mar-19 18895156 28-Feb-19 18895446 28-Feb-19 18896316 28-Feb-19 19055287 31-May-19 19029429 30-Apr-19 18991100 30-Apr-19 19043636 31-May-19 19001620 30-Apr-19 18964368 31-Mar-19 18978828 30-Apr-19 18913617 31-Mar-19 18948180 31-Mar-19 18947484 31-Mar-19 18881818 28-Feb-19 18871292 28-Feb-19 18848393 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 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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