Events

Persona (TASP) Tibial Articular Surface Provisional Shim 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Zimmer Pty Ltd 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
    RC-2015-RN-00013-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-01-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00013-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Zimmer is initiating this recall due to provisional shims being found with missing ball bearings. zimmer’s investigation has found that repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim.This gives rise to the potential for delays in surgery and/or a missing part from the device being left in the wound.This issue was also identified following worn returns being reported through the worn instrument program.No complaints from australia have been received regarding this issue.
  • 조치
    Customers are requested to inspect any product referenced within this notification before and after use for missing ball bearings and to provide any devices with missing ball bearings to your Zimmer sales representative for return. This action has been closed-out on 18/03/2016.

Device

Persona (TASP) Tibial Articular Surface Provisional Shim
  • 모델명 / 제조번호(시리얼번호)
    Persona (TASP) Tibial Articular Surface Provisional Shim All sizes and lots Catalogue Number: 42-5279-003-00 thru 42-5279-009-04 ARTG number: 109936
  • Manufacturer
    Zimmer Pty Ltd

Manufacturer

Zimmer Pty Ltd
  • 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
    DHTGA