Events

Device Recall Zyston Transform TLIF System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer Biomet Spine, 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
    74687
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2398-2016
  • 사례 시작날짜
    2016-06-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148222
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • 원인
    Zimmer bioment spine, inc. announces a voluntary field action for the zyston¿ transform instrument case and zyston¿ transform implant kit because the locking mechanism on the implant is not functioning as intended.
  • 조치
    Verbal notification of the decision to recall the product and related instructions was provided on June 30, 2016. Additionally, written notification of the decision to recall the product and related instructions will be provided to each of the individuals responsible for locations that have affected inventory under their control. Clear instructions and materials necessary to support the accountability and retrieval of product from the field will be provided with the recall notification. In order to ensure that the locations were alerted of the recall in a timely fashion, supplemental email notifications will also be sent to each recall notification addressee before distributing the recall documentation via Federal Express.

Device

Device Recall Zyston Transform TLIF System
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 2016244391; 2016244394; 2016244395; 2016244396; 2016244397; 2016244424; 2016244426; 2016244427; 2016244428; 2016244430.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.
  • 제품 설명
    Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
  • Manufacturer
    Zimmer Biomet Spine, Inc

Manufacturer

Zimmer Biomet Spine, Inc
  • 제조사 주소
    Zimmer Biomet Spine, Inc, 310 Interlocken Pkwy, Suite 120, Broomfield CO 80021-3479
  • 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
    USFDA