Events

Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 The Anspach Effort, 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
    63071
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0718-2014
  • 사례 시작날짜
    2011-09-09
  • 사례 출판 날짜
    2014-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-04-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112458
  • 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
    Bit, drill - Product Code HTW
  • 원인
    Recall was initiated due to the observation of separation between clear layers of the pouch during real time aging studies. as a result, it is possible to have a breach in the sterile barrier.
  • 조치
    Recalling firm notified direct accounts by letter on 09/09/11. Direct accounts were instructed to screen their inventory immediately for product packaged with the Tyvek Pouch/Tube Configuration, complete the reply form, and return the products to the firm.

Device

Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Japan, Canada, Nigeria, Guam, China, Czech Republic, Thialand, Ecuador, Lithuania, Argentina, Turkey, Cayman Island, Jamaica, India, Jordan, Germany, Brazil, Mexico, Israel, Cameroon, Switzerland, South Africa, Greece, Finland, Taiwan, Hong Kong, France, Spain, Cyprus, Australia, United Kingdom, Sweden, Bahama, Korea, Malaysia, Iceland, Portugal, Polan, Austria, Belgium, Egypt, Singapore, Netherland, Arab Emirates, Kenya, Italy, Venezula, Columbia, Dominican Republic, Chile, Panama, Honduras, Costa Rica, Philippines.
  • 제품 설명
    Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
  • Manufacturer
    The Anspach Effort, Inc.

Manufacturer

The Anspach Effort, Inc.
  • 제조사 주소
    The Anspach Effort, Inc., 4500 Riverside Dr, Palm Beach Gardens FL 33410-4235
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA