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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 Coilssee related information
Date Initiated by FirmJune 06, 2016
Date PostedJuly 11, 2016
Recall Status1 Terminated 3 on March 03, 2017
Recall NumberZ-2185-2016
Recall Event ID 74425
510(K)NumberK113412 K153658 
Product Classification Device, neurovascular embolization - Product Code HCG
ProductTarget Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035453040 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:M0035453040;  Lot Number/Expiration Date: 18603553 30-Sep-18 
Recalling Firm/
Manufacturer		 Stryker Neurovascular
47900 Bayside Pkwy
Fremont CA 94538-6515
For Additional Information ContactGeraldin 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
ActionStryker 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 Commerce45,302 (8,188 in the U.S.) - total, all model numbers
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = HCG
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