Events

Device Recall Stryker MIS Bur, 3.0mm Neuro Diamond 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Instruments Div. of Stryker Corporation 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
    53982
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0597-2010
  • 사례 시작날짜
    2009-07-06
  • 사례 출판 날짜
    2010-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-10-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86985
  • 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
    Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
  • 원인
    The bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both.
  • 조치
    Consignees were sent a letter dated 7/10/09 instructing them to locate and return product on hand for replacement. Surgeons who use the product were notified via a separate, untitled letter, dated July 13, 2009. A speed warning will be added to the product labels. Questions are directed to the firm at: 1-800-800-4236 ext. 3808.

Device

Device Recall Stryker MIS Bur, 3.0mm Neuro Diamond
  • 모델명 / 제조번호(시리얼번호)
    All lots distributed 1/30/06 through 3/4/09. Lots 06004017, 06034017, 06037017, 06037027, 06093017, 06165017, 06177017, 06353017, 07017017, 07046017, 07092017, 07095017, 07109017, 07143017, 07205017, 07233017, 07242017, 07248017, 07260017, 07316017, 07344017, 07351017, 08022017, 08030017, 08042017, 08051017, 08081017, 08108017, 08115017, 08133017, 08140017, 08155017, 08182017, 08210017, 08233017, 08255017, 08290017, 08296017, 08323017, 08357017 and 09040017.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: Australia, Canada, England, France, Hong Kong, Japan, Netherlands, South Africa, Sweden, Switzerland and Taiwan.
  • 제품 설명
    Stryker MIS Bur, 3.0mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-130.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • 제조사 주소
    Stryker Instruments Div. of Stryker Corporation, 4100 E. Milham Ave., Kalamazoo MI 49001
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA