Events

Device Recall Triathlon Revision Knee 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Howmedica Osteonics 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
    79661
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1512-2018
  • 사례 시작날짜
    2018-01-12
  • 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=162926
  • 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
    Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
  • 원인
    Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
  • 조치
    Branches/Agencies notified by email on 01/16/2018 and were asked to quarantine affected devices. Notification letters and product accountability forms were sent via UPS (with return receipt) on 01/15/2018. Customer notifications were updated and sent to consignees on 03/16/2018 as the technical and medical assessments associated with the issue were completed and additional information related to potential hazards and harms were identified.

Device

Device Recall Triathlon Revision Knee
  • 모델명 / 제조번호(시리얼번호)
    Catalog 5521-B-300, lot code ATV7IA Catalog 5521-B-400, lot code ATY40A
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Affected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition.
  • 제품 설명
    Knee Prosthesis, Sterile, Single-Use devices || Product Usage: || The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
  • Manufacturer
    Howmedica Osteonics Corp.

Manufacturer

Howmedica Osteonics Corp.
  • 제조사 주소
    Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA