Events

m/l taper with kinectiv technology femoral stems and necks 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Zimmer 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2015-06-23
  • 사례 출판 날짜
    2015-06-23
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150623.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: zimmer m/l taper with kinectiv technology femoral stems and necks the united states food and drug administration (fda) has issued medical device safety alerts concerning m/l taper with kinectiv technology femoral stems and necks, manufactured by zimmer. the manufacturer has initiated a voluntary recall of 64 lots (752 implants total) of m/l taper with kinectiv femoral stems and modular necks due to higher than allowed cytotoxicity levels found with the product. the manufacturer found a process monitoring failure that led to higher than expected amounts of manufacturing residues left on the devices. these residues can cause serious adverse health issues including allergic reactions, pain, infections, or death. use of these products may require the need for a revision surgery to replace the affected implant. according to the local supplier, the affected products are not distributed in hong kong. for details, please refer to the fda websites: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1699-2015&w=06172015&lang=eng http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm452012.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm451936.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 june 2015.

Device

m/l taper with kinectiv technology femoral stems and necks
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Orthopedic Devices
  • 제품 설명
    Medical Device Safety Alert: Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Necks
  • Manufacturer
    Zimmer

Manufacturer

Zimmer
  • 제조사 모회사 (2017)
    Zimmer Biomet Holdings
  • 제조사 의견
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    DH