Events

Smith & Nephew 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smith & Nephew, Inc., Endoscopy Div. 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
    72205
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0158-2016
  • 사례 시작날짜
    2015-09-10
  • 사례 출판 날짜
    2015-10-22
  • 사례 상황
    Completed
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140175
  • 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
    Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
  • 원인
    Sterility of device is compromised due to breach in the packaging.
  • 조치
    Smith & Nephew issued Recall Notification Letter dated September 10, 2015 via overnight Federal Express. Customers were requested to inspect inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. Complete the Inventory Return Certification Form on the following page, indicating the lot numbers and quantities that need to be returned and include your phone and fax number in the spaces provided. If you do not have product to return, please place an x in the column No product to return. Send the completed form to the Smith & Nephew's Field Action Department via email at FieldActions@smithnephew. com or fax +1-901-566-7975 to obtain a return authorization (RA) number. Return any affected product to the address listed on the Inventory Return Certification Form. Please indicate the RA number on your return shipment.

Device

Smith & Nephew
  • 모델명 / 제조번호(시리얼번호)
    50069280 50214249 50260936 50334160 50380067 50410625 50442600 50084563 50217938 50266144 50337465 50383809 50412120 50448621 50097669 50227860 50276674 50352665 50385382 50415177 50451051 50112174 50231228 50282533 50353524 50389835 50416603 50451744 50117989 50236270 50310331 50356943 50391478 50424410 50452069 50131406 50242373 50317889 50362696 50396029 50428473 50455380 50139181 50246739 50320168 50370396 50399036 50428686 50457280 50148410 50254144 50324084 50372214 50401621 50432549 50461109 50199543 50254145 50328908 50374300 50404803 50436553 50469462 50203454 50258249 50332285 50378312 50407329 50436675 50475144 50481307
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide, Canada, Austria, Australia, Belgium, China, Spain, Finland, France, Great Britain, Greece, Germany, Hungary, India, Italy, Japan, Korea, Lithuania, Latvia, Netherlands, Poland, Portugal, Sweden, Thailand, Turkey, Ukraine and Venezuela
  • 제품 설명
    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile || Part Number: 7209237 || Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
  • Manufacturer
    Smith & Nephew, Inc., Endoscopy Div.

Manufacturer

Smith & Nephew, Inc., Endoscopy Div.
  • 제조사 주소
    Smith & Nephew, Inc., Endoscopy Div., 130 Forbes Blvd, Mansfield MA 02048
  • 제조사 모회사 (2017)
    Smith & Nephew plc
  • Source
    USFDA