Events

Fixed Offset Adapter, A642100 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ossur North America 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
    66609
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0362-2014
  • 사례 시작날짜
    2013-10-24
  • 사례 출판 날짜
    2013-11-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-06-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122724
  • 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
    Component, external, limb, ankle/foot - Product Code ISH
  • 원인
    Ossur inititated a voluntary recall of the a-642100 fixed offset adapter because it can develop fatigue cracks in normal use over an extended period of time and ultimately separate completely.
  • 조치
    Ossur sent an "Safety Notice Voluntary Product Recall" letter dated October 29, 2013, via regular mail. Follow-up telephones are also made. The letter identified the product the problem and the actions to be taken by the customer. ¿ssur is committed to providing superior customer service and we will do our utmost to minimize any inconvenience this may cause your practice. To ensure patient safety we kindly ask you to take the following action: " Please identify the users of each of the A-642100 adapters, see attached list. " Also, please check your inventory for any A-642100s you may have on hand but have not fitted on users. A follow-up phone call will be made a few days later to coordinate replacements. A new replacement component will be provided to the customer. For further questions please call (949) 360-3634.

Device

Fixed Offset Adapter, A642100
  • 모델명 / 제조번호(시리얼번호)
    Item Number: A-642100    All Serial Numbers.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution including the states of AL, TX, NY, CA, VA, GA, WI, NC, ID and NJ.
  • 제품 설명
    Fixed Offset Adapter, A-642100. || The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other components. It is fully compatible with all standard 30mm prosthetic pylons. (3) Offset: 14,5mm (0.57inch).
  • Manufacturer
    Ossur North America Inc

Manufacturer

Ossur North America Inc
  • 제조사 주소
    Ossur North America Inc, 27051 Towne Centre Dr, Foothill Ranch CA 92610-2804
  • 제조사 모회사 (2017)
    Össur hf
  • Source
    USFDA