Events

Device Recall COMP PRIMARY STEM 8MM MINI 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
    78167
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0299-2018
  • 사례 시작날짜
    2017-06-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-03-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158817
  • 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
    Prosthesis, shoulder, semi-constrained, metal/polymer, uncemented - Product Code MBF
  • 원인
    Possibility that the patient label inside the product box was incorrectly labeled. the outer box label and actual product are correctly identified but the internal patient label could be incorrect.
  • 조치
    On June 5, 2017, Zimmer Biomet distributed Urgent Medical Device Recall notices to their customers via email and Fed Ex courier service. ***Risk Managers are advised to: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative to quarantine all affected product. 3. Work with your Zimmer Biomet sales representative in removing the affected product from your facility. 4. Confirm that the patient labels in your records are correct. 5. Complete the  Certificate of Acknowledgement and return a digital copy to corporatequality.postmarket@zimmerbiomet.com and retain a copy of the Acknowledgement Form with your recall records in the event of a compliance audit of your facilities documentation. ****Distributors, Sales Reps & Distributor Operation Managers are advised to: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form and return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification Form to Zimmer Biomet. a. Request a Recall Return Authorization Number via SMS or via email to rgarequest@zimmerbiomet.com (domestic) or via email to zimmerbiometintlirarequests@zimmerbiomet.com (international). b. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com. c. Include a hardcopy of Attachment 1 with your shipment for immediate processing. d. Mark the outside of the returns box(es) clearly with RECALL. Customers with further questions or concerns please call the customer call center at 1-574-371-3071 between 8:00 am and 5

Device

Device Recall COMP PRIMARY STEM 8MM MINI
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 523080
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide in US; Internationally Argentina, Netherlands & Canada
  • 제품 설명
    COMP PRIMARY STEM 8MM MINI, model # 113628
  • 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