Events

Integra Titan Reverse Shoulder System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Integra LifeSciences Corp. 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
    69596
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0197-2015
  • 사례 시작날짜
    2014-10-24
  • 사례 출판 날짜
    2014-11-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-07-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131021
  • 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, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
  • 원인
    A single lot of left and a single lot of right reverse shoulder system cutting templates were manufactured incorrectly. specifically, the threaded handle has been welded backwards on the template resulting in the cutting angle being the reverse of what it should be.
  • 조치
    The recalling firm will notify their consignees via letter delivered by traceable courier service. The consignee will be asked to complete and return a form to the recalling firm stating if they have affected product or not.

Device

Integra Titan Reverse Shoulder System
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers PM0278 and PM0277
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including the states of TX, CA, OH, MS, VA, IL, TN, GA, CA, FL, and AZ.
  • 제품 설명
    Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees. || The Reverse Shoulder System Cutting Template, 142.5 degrees is an accessory for use with the Integra Titan Reverse Shoulder System. It is used to project the osteotomy angle on the humeral head.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.