Events

DHS / DCS MEDIUM INSTRUMENT Technical Name: SURGICAL INSTRUMENTS ANVISA Registration Number: 80145901733 Hazard Class: I Affected Model: Instrumental Non-Articulated No Shearing Affected Series Numbers: SKU: 338.260 || Lot: All lot numbers <8016184 SKU: 338.280 || Lot: All lot numbers <7985313 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Synthes GmbH 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
    2108
  • 날짜
    2016-10-27
  • 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
    We have recorded that your facility has received the product (s) subject to this recall. It is important to note that withdrawal of the product would prevent emergency surgery, so Synthes GmbH is not requiring immediate removal of the affected product (s). Synthes GmbH is in the process of developing a plan for the recovery and replacement of the indicated devices and will contact you as soon as the replacement part becomes available.
  • 원인
    There is no evidence of the biocompatibility of the material of the dhs / dcs no. 338.280 impact insert, single (part number 338.260), used in the existing product (specified lots) (polyamide 6.6 with 20% reinforcement in carbon fiber, tecamid 66 cf 20 ). synthes has not performed biocompatibility tests for this material, and there is no evidence that it has been performed by other entities.
  • 조치
    Field Action Code R2014204R triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will make collection for later return to the manufacturer.

Device

DHS / DCS MEDIUM INSTRUMENT Technical Name: SURGICAL INSTRUMENTS ANVISA Registration Number: 8014...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Synthes GmbH