Events

Trade Name: Reverse Shoulder System Comprehensive Technical Name: Reverse Total Shoulder Arthroplasty System ANVISA Registration Number: 80044680228 Hazard Class: IV Model Affected: XL-115363; XL-115367 Serial numbers affected: XL-115363/488830; XL-115367/630520 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Biomet 3I do Brasil Comércio de Aparelhos Médicos Ltda; Biomet Orthopedics 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
  • 사례 ID
    2317
  • 날짜
    2017-06-20
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • 데이터 추가 비고
    Segregate the affected products and inform Zimmer Biomet in case of an adverse event.
  • 원인
    Zimmer biomet is conducting a field action for some specific batches of polyethylene implants. affected products are being collected because of the potential presence of elevated levels of endotoxin that exceed the specification limit (20 eu / device). the problem was discovered during routine bacterial endotoxin (bet) tests on three samples of polyethylene implants over a 6-week period that exceeded that level. there were no complaints received regarding this issue.
  • 조치
    Field Action Code ZFA 2017-43 triggered under the responsibility of Biomet 3I of Brasil Comércio de Aparelhos Médicos Ltda. Company will collect for further destruction of the product.

Device

Trade Name: Reverse Shoulder System Comprehensive Technical Name: Reverse Total Shoulder Arthropl...

Manufacturer

Biomet 3I do Brasil Comércio de Aparelhos Médicos Ltda; Biomet Orthopedics
  • 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
    ANVSANVISA