Events

Device Recall Target Detachable Coils 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Neurovascular 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    74425
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2166-2016
  • 사례 시작날짜
    2016-06-06
  • 사례 출판 날짜
    2016-07-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147551
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Device, neurovascular embolization - Product Code HCG
  • 원인
    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.
  • 조치
    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.

Device

Device Recall Target Detachable Coils
  • 모델명 / 제조번호(시리얼번호)
    MODEL Number: M0035431020;  Lot Number/Expiration Date: 18785369 31-Jan-19 18741318 30-Nov-18 18719333 30-Nov-18 18583254 30-Sep-18 18557530 31-Aug-18 18429528 30-Jun-18 18818792 31-Jan-19 18801607 31-Jan-19 18772009 31-Dec-18 18771835 31-Dec-18 18758722 31-Dec-18 18748395 31-Dec-18 18740448 30-Nov-18 18709718 30-Nov-18 18725975 30-Nov-18 18726385 30-Nov-18 18544137 31-Aug-18 18517433 31-Jul-18 18447952 30-Jun-18 18818618 31-Jan-19 18818444 31-Jan-19 18740738 30-Nov-18 18544079 31-Aug-18 18510936 31-Jul-18 18824386 31-Jan-19 18784557 31-Jan-19 18772067 31-Dec-18 18741608 31-Dec-18 18686476 30-Nov-18 18568905 31-Aug-18 18517549 31-Jul-18 18824444 28-Feb-19 18824502 31-Jan-19 18818270 31-Jan-19 18758107 31-Dec-18 18726180 30-Nov-18 18686650 30-Nov-18 18664543 31-Oct-18 18647231 31-Oct-18 18647173 31-Oct-18 18568963 31-Aug-18 18458590 30-Jun-18 18391277 31-May-18 18824328 31-Jan-19 18802922 31-Jan-19 18748105 31-Dec-18 18647115 31-Oct-18 18568847 31-Aug-18 18557472 31-Aug-18 18786181 31-Jan-19 18772183 31-Dec-18 18686534 30-Nov-18 18585000 31-Aug-18 18584194 31-Aug-18 18582103 30-Sep-18 18582045 30-Sep-18 18557356 31-Aug-18 18510878 31-Jul-18 18523236 31-Jul-18 18772125 31-Dec-18 18686418 30-Nov-18 18647289 31-Oct-18 18452822 30-Jun-18 18450373 30-Jun-18 19033545 30-Apr-19 19004591 30-Apr-19 19004475 30-Apr-19 19004417 30-Apr-19 18927253 31-Mar-19 18915458 31-Mar-19 18915748 31-Mar-19 18915574 31-Mar-19 18915516 31-Mar-19 18845790 28-Feb-19 19052916 31-May-19 18976256 30-Apr-19 18976844 30-Apr-19 18976550 30-Apr-19 18895388 28-Feb-19 18895098 28-Feb-19 19031967 30-Apr-19 18976403 30-Apr-19 19063228 31-May-19 18941012 31-Mar-19 18957807 31-Mar-19 18896258 28-Feb-19 18865965 28-Feb-19 18885463 28-Feb-19 18845411 28-Feb-19 18984961 30-Apr-19 19032257 30-Apr-19 19031387 30-Apr-19 18928771 31-Mar-19 18928012 31-Mar-19 18846169 31-Jan-19 18866197 28-Feb-19 18846548 28-Feb-19 19052595 31-May-19 18957227 31-Mar-19 18956647 31-Mar-19 18866658 28-Feb-19 18886877 28-Feb-19 19031677 30-Apr-19 19076325 31-May-19 18941476 31-Mar-19 18895678 31-Mar-19 18915690 31-Mar-19 18915632 31-Mar-19 18866890 28-Feb-19 18866429 28-Feb-19 19052274 31-May-19 19065800 31-May-19 19004533 30-Apr-19 19004359 30-Apr-19 18941940 31-Mar-19 19051953 31-May-19 18976697 30-Apr-19 18895968 28-Feb-19.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    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.
  • 제품 설명
    Target Detachable Coils: || TARGET HELICAL NANO 1 MM X 2 CM || MODEL Number:M0035431020 || Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
  • Manufacturer
    Stryker Neurovascular

Manufacturer

Stryker Neurovascular
  • 제조사 주소
    Stryker Neurovascular, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA