Stryker Neurovascular: Medical Device Recall in 2016 - (Recall #: Z-2184-2016)
See the recall detail below. You can also see other recalls from the same firm in 2016.
Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035452560 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Class II
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.
MODEL Number:M0035452560; Lot Number/Expiration Date: 18426504 31-May-18 18780350 31-Jan-19 18426444 31-May-18 18532556 31-Aug-18 18794332 31-Jan-19 18830452 31-Jan-19 19036717 31-May-19 19005693 30-Apr-19 19060276 31-May-19 18939358 31-Mar-19 19056621 31-May-19 19037970 31-May-19 18971989 30-Apr-19 18906402 28-Feb-19 18953265 31-Mar-19 18897969 28-Feb-19
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.
Voluntary: Firm initiated