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-2165-2016
  • 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=147547
  • 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: M0035431010   Lot Number/Expiration Date: 18784731 31-Jan-19 18767279 31-Dec-18 18685490 30-Nov-18 18592036 30-Sep-18 18818328 31-Jan-19 18723284 30-Nov-18 18630215 31-Oct-18 18601959 30-Sep-18 18414374 31-May-18 18748453 31-Dec-18 18730570 30-Nov-18 18606940 30-Sep-18 18403443 31-May-18 18818502 31-Jan-19 18796245 31-Jan-19 18627513 31-Oct-18 18601901 30-Sep-18 18581353 30-Sep-18 18484777 31-Jul-18 18818676 31-Jan-19 18777759 31-Dec-18 18484661 31-Jul-18 18429414 30-Jun-18 18801963 31-Jan-19 18803278 31-Jan-19 18786355 31-Jan-19 18776711 31-Dec-18 18767778 31-Dec-18 18723052 30-Nov-18 18539797 31-Aug-18 18417674 31-May-18 18831860 31-Jan-19 18818850 31-Jan-19 18739085 30-Nov-18 18833082 31-Jan-19 18748163 31-Dec-18 18738163 30-Nov-18 18602017 30-Sep-18 18581469 31-Aug-18 18543905 31-Aug-18 18450658 30-Jun-18 19002735 30-Apr-19 18941882 31-Mar-19 18941418 31-Mar-19 18930269 31-Mar-19 18894264 28-Feb-19 18893885 28-Feb-19 18885637 28-Feb-19 18957343 31-Mar-19 18956763 31-Mar-19 18940954 31-Mar-19 18857373 28-Feb-19 18975521 30-Apr-19 18975084 30-Apr-19 18847507 28-Feb-19 18930614 31-Mar-19 18847275 31-Jan-19 19002909 30-Apr-19 18929924 31-Mar-19 18847333 31-Jan-19 19062880 31-May-19 19002851 30-Apr-19 19002677 30-Apr-19 18974210 30-Apr-19 18930959 31-Mar-19 18906932 31-Mar-19 19046992 31-May-19 19002793 30-Apr-19 18893506 28-Feb-19 18887051 28-Feb-19 18847391 28-Feb-19 18984787 30-Apr-19 19037618 31-May-19 19064752 31-May-19 18894643 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 1 CM || MODEL Number:M0035431010 || 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