6 MM X 25 MM X 200 MM HA COATED HALF PIN SST 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smith & Nephew Inc 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
    61767
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1744-2012
  • 사례 시작날짜
    2012-04-13
  • 사례 출판 날짜
    2012-06-06
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-09-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Pin, fixation, threaded - Product Code JDW
  • 원인
    Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
  • 조치
    Smith & Nephew Sales Representatives and Smith & Nephew International Distributors were notified of the problem with the affected product and the recall via email on April 13, 2012. All affected direct consignees were notified via Fed Ex on April 13, 2012. The Urgent Medical Device Recall letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease use and distribution of the product and quarantine them immediately for return. Customers were instructed to complete the Inventory Return Certification Form included with the letter. Customers should fax or email the form to 901-566-7975 or fieldactions@smith-nephew.com. The affected product should be returned to: Smith & Nephew Attn: Global Field Actions Safety Affairs 1450 Brooks Road Memphis, Tennessee 38116 If the affected product was distributed further customers were instructed to provide a copy of the recall letter to these customers.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 06ET97810A, 06FT99046A, 07DT07878A, 08DT18961A, 09FT32607, 09FT32607A, 09GT34292, 09MT38252, 10BT39227, 10CT40106, 10JT46318, 10KT00278, 10MT02005, 11BT03212, 11CT04325, 11ET06842, 11FT07890, 11JT10396, 11KT11400, 11LT12160
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey
  • 제품 설명
    6 MM X 25 MM X 200 MM HA COATED HALF PIN SST, REF 71070803, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Smith & Nephew Inc, 1450 E. Brooks Rd, Memphis TN 38116
  • 제조사 모회사 (2017)
  • Source
    USFDA