Events

translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Saudi Food & Drug Authority에 따르면, 해당 translation missing: ko.activerecord.attributes.event.types.recall_field_safety_notice 는 Saudi Arabia 에서 Zimmer inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 096 07 12 000
  • 사례 시작날짜
    2012-07-29
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=2131
  • 비고 / 경고
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
  • 데이터 추가 비고
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    The issue concerns a mix up of two lots of ncb screws with different lengths but the same diameter (4mm). ncb screws with a length of 26mm were placed in the 32 mm packaging and vice versa. these trauma screws are delivered non sterile and are placed in the implant rack and sterilized before use. as a general practice, screw length is checked before placing the screw into the right place of the implant rack (figure 1). this is done using a template which is incorporated into the rack itself. during the surgery, when picking a screw, the nurse checks the length of screw once again using the same template.

Device

Fixation system, Internal orthopaedic fixation system, plate/screw
  • 모델명 / 제조번호(시리얼번호)
    NCB screws 4.0 self taping screws; Model number: 02.03155.032 (32 mm); 02.03155.026 (26 mm) Lot/batch no.: 2649944 (32 mm), 2649941 (26 mm)
  • 제품 설명
    Non-biodegradable, self taping screws
  • Manufacturer
    Zimmer inc

Manufacturer

Zimmer inc
  • 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.
  • 제조사 대표
    Ebrahim M. Al-Mana & Bros. Co. Ltd.
  • Source
    SFDA