Events

Otto Bock Modular Knee Joint, 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bock,Otto,Orthopedic Ind,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
    50486
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0537-2010
  • 사례 시작날짜
    2008-10-28
  • 사례 출판 날짜
    2009-12-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75488
  • 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
    External Limb Knee Joint Component - Product Code ISY
  • 원인
    Otto bock health care lp has discovered that in some cases, the securing screws of the joint axes may not have been properly mounted. this can cause the axes to gradually move out of the joint and result in a risk of falling for the user.
  • 조치
    Consignees were sent on 10/28/08 a Otto Bock "Urgent: Correction Notice" letter dated October 27, 2008. The letter described the product and problem. It provided instructions if the product was in stock and instructed the consignee to contact the patients (a patient letter was provided) and to complete and return the reply card. Consignees were to contact Otto Bock at their Customer Service to request a return authorization.

Device

Otto Bock Modular Knee Joint,
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 200803001, 200803002, 200803003, 200803004, 200803005, 200803006, 200803007, 200803008, and 200803009.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    The product was only distributed within the US by the US company. Any OUS distribution was handled by the manufacturer in Germany.
  • 제품 설명
    Otto Bock Modular Knee Joint, 3R66, Otto Bock HealthCare GmbH, Max-Nader-StraBe 15 . 37115 Duderstadt /Germany. || Pediatric Prosthetic Device used by Lower Limb amputees.
  • Manufacturer
    Bock,Otto,Orthopedic Ind,Inc

Manufacturer

Bock,Otto,Orthopedic Ind,Inc
  • 제조사 주소
    Bock,Otto,Orthopedic Ind,Inc, Two Carlson Parkway North, Suite 100, Minneapolis MN 55447
  • Source
    USFDA