Events

Device Recall Smith & Nephew Endoscopic Disposable Blades 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
    52042
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1562-2009
  • 사례 시작날짜
    2009-05-07
  • 사례 출판 날짜
    2009-07-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81976
  • 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
    Endoscopic Disposable Blades - Product Code NBH
  • 원인
    Product sterility is compromised due to breach in the sterile packaging.
  • 조치
    Smith & Nephew, Inc. issued a notification letter dated May 5, 2009 via Federal Express to User Facility and/or Sales Representatives on May 7, 2009 and an Email was sent to Sales Representatives. Accounts were requested to 1)complete the form and fax to Smith & Nephew, Inc. at 1-508-261-3636 and 2) return (using the firm's return authorization number) affected product to Smith & Nephew, Inc. Direct questions about this recall to Smith & Nephew, Inc. by calling 1-508-261-3655.

Device

Device Recall Smith & Nephew Endoscopic Disposable Blades
  • 모델명 / 제조번호(시리얼번호)
    Lot #: 20153855.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, Switzerland, Canada, United Arab Emerites, Belgium, Mexico, South Africa, Great Britain, Australia, Korea, Japan, Germany, Israel, India, Taiwan, Greece, Italy, Turkey and Chile.
  • 제품 설명
    Smith & Nephew Endoscopic Disposable Blades: || NOTCHBLASTER ABR,EP-1,5.5 DSPL || Part #: 7205329. || DYONICS Series 3000 BONECUTTER Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty.
  • 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