Events

Device Recall ALPS 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
    77594
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0516-2018
  • 사례 시작날짜
    2017-06-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-06-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159248
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • 원인
    A raw material anomaly was discovered in four lots of raw material and has the potential to be on or below the surface of the device components which can increase the risk of instrument fracture.
  • 조치
    On June 12, 2017, Zimmer Biomet distributed Urgent Medical Device Recall Removal and Certificates of Acknowledgement notices to their customers via email and FedEx. Risk Manager Customer Responsibilities are the following: 1. Review the notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative and quarantine all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility. 4. Complete and return the Certificate of Acknowledgement via email to: corporatequality.postmarket@zimmerbiomet.com and retain a copy in your records. 5. If after reviewing the notice and if you have further questions or concerns please call the customer call center at 1-574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Alternatively, your questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com.

Device

Device Recall ALPS
  • 모델명 / 제조번호(시리얼번호)
    231220200 Item Number with the following Lot numbers 45785,46151, 47467, 48461, 48809, 100016 & 102325  231220202 Item Number with the following Lot Numbers: 45790, 48477, 48811,  100017, 101028 & 102338
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA MD, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WV. Internationally to: Australia, Chile, Cost Rica, Ecuador, Netherlands, Panama & Switzerland
  • 제품 설명
    DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE
  • 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