Events

Device Recall Gentle Threads 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer Biomet, 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
    79682
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1739-2018
  • 사례 시작날짜
    2018-03-28
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162987
  • 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
    soft tissue fixation screw - Product Code HWC
  • 원인
    Specific lots of the device were overexposed during eto sterilization. this may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
  • 조치
    The recalling firm issued letters to Distributors as well as to affected Risk Managers and Surgeons. Distributors were instructed to ensure affected team members are aware of the contents of the recall notification, locate and quarantine affected product in inventory, return all affected product from distributorship and from affected hospitals, and submit a list of any additional customer accounts that were not notified of the recall to the recalling firm. Risk Managers were instructed to ensure affected personnel are aware of the contents of the recall notification, quarantine all affected product, and complete the included Certificate of Acknowledgement and return to the recalling firm, even if no affected products were present at the facility. Surgeons were instructed to review the notification and return the completed Certificate of Acknowledgement. Customers' questions and concerns were directed to the recalling firm's customer service at 574-371-3071, 8AM-5PM EST, Monday through Friday. Alternatively, questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.

Device

Device Recall Gentle Threads
  • 모델명 / 제조번호(시리얼번호)
    lot 326980, 371540
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution. US nationwide, Netherlands, Mexico, Paraguay, Brazil, Argentina, Malaysia, Costa Rica, Chile, South Korea, and Canada.
  • 제품 설명
    Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee.
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • 제조사 주소
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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