Events

TAPERED SCREW VENT TRABECULAR METAL IMPLANT (4.1MM X 8MM - 6.0MM X 13MM) 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 ZIMMER BIOMET DENTAL CANADA INC. / ZIMMER BIOMET DENTAIRE CANADA INC. 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
    84775
  • 사례 위험등급
    II
  • 사례 시작날짜
    2012-04-23
  • 사례 국가
    Canada
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    Precautions have been added to the instructions for use indicating additional information regarding the placement of a 4.1mm diameter trabecular metal implant in mandibles with dense (type d1) thick inferior border. this follows a complaint where the apical tip of a 4.1mmd implant separated from the implant during surgery.

Device

TAPERED SCREW VENT TRABECULAR METAL IMPLANT (4.1MM X 8MM - 6.0MM X 13MM)
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: TMM4B11 (Lot serial: 61992706); Model Catalog: TMM4B13 (Lot serial: 61992706); Model Catalog: TMM4B10 (Lot serial: 61973167); Model Catalog: TMM4B11 (Lot serial: 61973167); Model Catalog: TMM4B13 (Lot serial: 61973167); Model Catalog: TMM4B10 (Lot serial: 61992706); Model Catalog: TMM4B11 (Lot serial: 61977019); Model Catalog: TMM4B13 (Lot serial: 61977019); Model Catalog: TMM4B10 (Lot serial: 61977020); Model Catalog: TMM4B11 (Lot serial: 61977020); Model Catalog: TMM4B13 (Lot serial: 61977020); Model Catalog: TMM4B10 (Lot serial: 61977019)
  • 제품 설명
    TRABECULAR METAL IMPLANTS 4.1MMD
  • Manufacturer
    ZIMMER BIOMET DENTAL CANADA INC. / ZIMMER BIOMET DENTAIRE CANADA INC.

Manufacturer

ZIMMER BIOMET DENTAL CANADA INC. / ZIMMER BIOMET DENTAIRE CANADA INC.
  • 제조사 주소
    MISSISSAUGA
  • 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
    HC