Events

Device Recall Integra 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
    74855
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2600-2016
  • 사례 시작날짜
    2016-07-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148608
  • 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
    Screw, fixation, bone - Product Code HWC
  • 원인
    Labeling on the qwix screw product states that it is a "compression screw" instead of a "positioning screw".
  • 조치
    Integra sent an Urgent Voluntary Medical Device Recall letter and acknowledgement return response form dated July 21, 2016 to their affected customers. The recall letter identifies the product and lots involved, problem and actions to be taken. All customers are asked to return the completed acknowledgement and return response form by email to FCA1@integralife.com or fax to 1-609-275-9445. Should any customer has any questions regarding the instructions, they can contact Customer Service at 1-800-654-2873.

Device

Device Recall Integra
  • 모델명 / 제조번호(시리얼번호)
    Model Numbers: 121530S, 121535S, 121540S, 121545S, 121550S, 121555S, 121560S, 121565S, 121570S, 121575S, 121580S, 121740S, 121745S, 121750S, 121755S, 121760S, 121765S, 121770S, 121775S, 121780S, 121785S, 121790S, 121795S, 121800S, 121805S, 121810S, 121815S and 121820S
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution in the states of AL, GA, ID, MA, MD, MN, NC, NJ, NY, OH, OK, PA, PR, TX, VA and WA
  • 제품 설명
    Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, || Product Usage: The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.