Events

ArthroWand Saber 30 with Integrated Cable wand 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ArthroCare 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
    52722
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1900-2009
  • 사례 시작날짜
    2008-08-05
  • 사례 출판 날짜
    2009-08-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-06-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83815
  • 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
    Electricsurgical cutting and coagulation device - Product Code GEI
  • 원인
    Potential sterility loss-- due to wearing or puncture in the tyvek lid, the product may lose sterility.
  • 조치
    Firm initiated this recall on August 5, 2008. Consignees were notified via letter asking them to contact consignees and delivered via courier. Distribution discontinued on July 9, 2008.

Device

ArthroWand Saber 30 with Integrated Cable wand
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 4T011660-A, 4T01670-A, 4T01670-B, 4T02460-A, 4T02670-A, 4T02980-A, 4T02980-B, 4T03160-A, 4T04480-A, 4T04480B, 4T04860-A, 4T04980-A, 4T04980-B, 4T06680-A, 4T06680-B, 4T06770-A, 4T07360-A, 4T07460-A, 4T07880-A, 4T08580-A, 4T09270-A, 4T09370-A, 4T09370-B, 4T09370-C, 4T09380-A, 4T09460-A, 4T09580-A, 4T09880-A, 4T10980-A, 4T12260-A, 4T12680-A, 4T12970-A, 4T13380-A, 4T13960-A, 4T13960-B, 4T14980-A, 4T14980-B, 4T15680-A, 4T16360-A, 4T17670-A, 4T17770-A, 4T18760-A, 4T18760-B, 4T18860-A, 4T19770-A, 4T20260-A, 4T20570-A, 4T20660-A, 4T21050-A, 4T22960-A, 4T22960-B, 4T22970-A, 4T24270-A, 4T24270-B, 4T24960-A, 4T25650-A, 4T26970-A, 4T27160-A, 4T27750-A, 4T28260-A, 4T28260-B, 4T29350-A, 4T30270-A, 4T30370-A, 4T32050-A, 4T32060-A, 4T32770-A, 4T33260-A, 4T34150-A, and 4T34960-A.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution including USA and countries of Netherlands, Slovak Republick, Ireland, Spain, Switzerland, Singapore, Russian Federatin, Greece, Japan, Saudi Arabia, India, Slovenia, Israel, South Africa, South Korea, Poland, Thailand, Jordan, Belgium, Finland, Portugal, Cyprus, Italy, UAE, Kuwait, China, Bahrain, Denmark, Norway, Sweden, Australia, Germany, Austria, UK, New Zealand, Mexico and Canada.
  • 제품 설명
    ArthroWand Saber 30 with Integrated Cable wand, Catalog number AC4330-01, Manufactured by ArthroCare Corporation, Sunnyvale, CA
  • Manufacturer
    ArthroCare Corporation

Manufacturer

ArthroCare Corporation
  • 제조사 주소
    ArthroCare Corporation, 680 Vaqueros Ave, Sunnyvale CA 94085-3523
  • Source
    USFDA