Device Recall METS 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stanmore Implants Worldwide Ltd. 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
    75892
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0822-2017
  • 사례 시작날짜
    2016-12-07
  • 사례 출판 날짜
    2016-12-19
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-07-17
  • 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
    Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
  • 원인
    The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
  • 조치
    Stanmore Implants sent an Urgent Field Safety Notice dated November 25, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to immediately check their internal inventory and quarantine all subject devices, circulate the Field Safety Notice internally to all interested/affected parties, maintain awareness of the notice internally until all required actions have been completed within their facility, inform Stanmore Implants if any of the subject devices have been distributed to other organizations, complete the attached customer response form and list of affected batches form, return the completed form and any affected devices to their S/W Representative. Customers with questions were instructed to contact their local sales representative.

Device

  • 모델명 / 제조번호(시리얼번호)
    B10191, B10443, B9920, B10561, B9921, B9922
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA
  • 제품 설명
    Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm || The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
  • Manufacturer

Manufacturer

  • 제조사 주소
    Stanmore Implants Worldwide Ltd., 210 Centennial Avenue Centennial Park, Centennial Park, Borehamwood United Kingdom
  • 제조사 모회사 (2017)
  • Source
    USFDA