Events

Device Recall Smith & Nephew 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smith & Nephew, Inc. Endoscopy Division 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
    59329
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3050-2011
  • 사례 시작날짜
    2011-07-07
  • 사례 출판 날짜
    2011-08-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-07-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102284
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • 원인
    Shaft tip (casting) does not meet the sne 416 specification, which could result in rusting of the tendon strippers.
  • 조치
    Smith & Nephew sent an Urgent - Product Recall Notification letter dated July 7, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the form included in the letter and return to Hoangthi.le@smith-nephew.com or fax to 508-261-3620. Each affiliate must then notify each facility affected by the recall. To return product and obtain credit or order replacement product customers should contact the Smith & Nephew Endoscopy Returns at 800-343-5717 (option 3) for a Return Authorization (RA) or send an email to, endo.andreturns@smith-nephew.com. For questions, contact Hoangthi by phone at 508-337-3731.

Device

Device Recall Smith & Nephew
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 50342499, 50344799, 50347017, 50349339 50354170, 50357485, 50360691, 50360992 50367247, 50374544, 50375820, 50370949 50371944
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Belgium, Canada, Chile, China, Columbia, Denmark, Dubai, Finland, France, Germany, Greece, Hong Kong, India, Italy, Israel, Japan, Korea, Malaysia, Mexico, Netherland, Norway, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom, and Venezuela
  • 제품 설명
    Smith & Nephew, Tendon Stripper, Slotted, 5.0 mm I.D. x || 12 working length. Non-Sterile || Catalog Number: 013554 || Orthopedic Manual Surgical Instrument
  • Manufacturer
    Smith & Nephew, Inc. Endoscopy Division

Manufacturer

Smith & Nephew, Inc. Endoscopy Division
  • 제조사 주소
    Smith & Nephew, Inc. Endoscopy Division, 150 Minuteman Drive, Andover MA 01810-1031
  • Source
    USFDA