Events

Device Recall SYMBIONIC LEG 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ossur Americas, 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
    67249
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0936-2014
  • 사례 시작날짜
    2012-02-12
  • 사례 출판 날짜
    2014-02-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-02-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125089
  • 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 initiated this recall of the symbionic leg because it may have a possible defect in a small batch of electronics.
  • 조치
    OSSUR contacted all affected customers via phone on February 12, 2013, informing them that a voluntary recall for this product has been implemented, along with the recommended instructions to return the product. A new replacement prosthetic will be provided to the customer. OSSUR has inspected and made appropriate modification to all inventory. ¿ssur will also further strengthen the design and our manufacturing process to ensure an even more robust product. For further questions please call (949) 303-3239.

Device

Device Recall SYMBIONIC LEG
  • 모델명 / 제조번호(시리얼번호)
    Item Numbers: SBL12012, SMBL5250, SBL12903, SMBL5270, SMBL2240, SMBL5280, SMBL3260, SMBL7290, SMBL3280, Serial Numbers: 321195, 321201, 710326, 710328, 710335, 710339, 710340, 710353, 710355, 710365, 710390, 710396, 710399, 710405, 710407, 710411 and 710413
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution including the states of AL, DC, GA, NY, NJ, OK and PA.
  • 제품 설명
    The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. || The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products from ¿ssur. Both are a battery powered micro-processor controlled prosthetic device and are connected through a shared battery. The knee and the foot have different sensor systems that provide real-time information used to control knee joint resistance and the flexion/extension of the ankle during the gait cycle. Default control parameters are provided with the device but can be manually adjusted by a certified prosthetist through software (knee), or by a certified prosthetist or the user through controls on the device itself (foot). || SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25  30 and less than 100kg for foot Categories 22, 23 and 24. The system is not intended for athletic use.
  • Manufacturer
    Ossur Americas, Inc.

Manufacturer

Ossur Americas, Inc.
  • 제조사 주소
    Ossur Americas, Inc., 19762 Pauling, Foothill Ranch CA 92610-2611
  • 제조사 모회사 (2017)
    Össur hf
  • Source
    USFDA