Events

OTTO BOCK Kenevo knee joints 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Otto Bock Healthcare Product 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
    79019
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0814-2018
  • 사례 시작날짜
    2017-09-12
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161205
  • 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
    Joint, knee, external limb component - Product Code ISY
  • 원인
    Otto bock healthcare products gmbh has identified a design issue through extended durability testing where the pylon clamping mechanism has the potential to cause damage to the pylon. when used longer than 1.45 million cycles (which represents approximately 2.3 years of use of the knee joint under heavy usage conditions), and the pylon clamp is overtightened according to the labeled torque specification, and the patient weighs at most 125kg it may be remote that the pylon breaks, and causing the patient to fall. there have been no failures or complaints reported directly attributed to the failure mode collapsed pylon. in the us market and in canada, labeling requires a condition based service at three years. in the rest of the world, a mandatory two year service interval is specified. only the devices in distribution in the united states and canada are affected by this action.
  • 조치
    On September 14, 2017 a letter was sent to all their consignees via 2nd day signature receipt required to customers instructing them to contact their patients and send in their devices for service within the first 2.3 years of use. The pylon clamp will be replaced at no charge. The pylon will also be inspected and replaced if necessary. The customer will be requested to complete a reply form indicating they have received the notice and intend to contact their patients to arrange for the requested service. Customer Service: (800) 328-3458  Option 1 Loaner Service: (800) 328-3458  Option 3, then Option 1

Device

OTTO BOCK Kenevo knee joints
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers:  201520007, 201520010, 201520012, 201520008, 201520009, 201522040, 201520002, 201520011, 201520006, 201522046, 201522043, 201520028, 201528134, 201528139, 201520013, 201522045, 201525069, 201525109, 201524051, 201524050, 201549087, 201550012, 201550020, 201550022, 201550017, 201550028, 201550027, 201550016, 201550036, 201550014, 201551005, 201550025, 201551028, 201551030, 201550040, 201551032, 201602031, 201602030, 201603014, 201603016, 201603023, 201602034, 201602036, 201602032, 201551034, 201603029, 201603027, 201603028, 201610008, 201601018, 201610010, 201610015, 201610019, 201610022, 201610020, 201611001, 201611010, 201520027, 201610030, 201610035, 201611012, 201603025, 201611002, 201611018, 201612018, 201612020, 201613021, 201613019, 201615008, 201618017, 201616010, 201613008, 201616004, 201616005, 201616012, 201618023, 201618021, 201618018, 201618019, 201618024, 201617031, and 201618025.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    AK, AR, AZ, CA, CT, DC, GA, IL, IN, KY, LA, MD, MI, MN, NC, ND, NJ, MN, NY, OH, OK, OR, PA, PR, TX, VA, and WA AU, BE, DE, FR, GB, IT, KW, LU, NL, NO, AT, SA, SE, CH, ES, ZA, and HU
  • 제품 설명
    OTTO BOCK Kenevo knee joints Model 3C60
  • Manufacturer
    Otto Bock Healthcare Product

Manufacturer

Otto Bock Healthcare Product