Events

Device Recall Ziptight Ankle Syndesmosis Fixation 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
    79973
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1915-2018
  • 사례 시작날짜
    2017-08-22
  • 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=164064
  • 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
    Fastener, fixation, nondegradable, soft tissue - Product Code MBI
  • 원인
    The product was packaged without the tip protectors.
  • 조치
    August 22, 2017 letter to Risk Managers and Surgeons includes the following instructions: Risk Manager Responsibilities: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative quarantine all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility. 4. Complete Attachment 1  Certificate of Acknowledgement. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com. b. Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation. 5. If after reviewing this notice 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. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this field action that are recommended beyond your existing follow up schedule. 3. Complete Attachment 1  Certificate of Acknowledgement. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com. b. Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your documentation. 4. If after reviewing the notice you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergenc

Device

Device Recall Ziptight Ankle Syndesmosis Fixation
  • 모델명 / 제조번호(시리얼번호)
    Lot #: 058860, 058880, 058890, 058910, 116030, 169780, 169790, 213450, 213480, 374420, 392530, 476670, 503830, 614910, 670640, 728190, 984070, 984080;  UDI #:  (01)00880304476103(17)220523(10)058860,  (01)00880304476103(17)220608(10)058880,  (01)00880304476103(17)220608(10)058890,  (01)00880304476103(17)220608(10)058910,  (01)00880304476103(17)220519(10)116030,  (01)00880304476103(17)220609(10)169780,  (01)00880304476103(17)220608(10)169790,  (01)00880304476103(17)220609(10)213450,  (01)00880304476103(17)220607(10)213480,  (01)00880304476103(17)220319(10)374420,  (01)00880304476103(17)220610(10)392530,  (01)00880304476103(17)220607(10)476670,  (01)00880304476103(17)220608(10)503830,  (01)00880304476103(17)220421(10)614910,  (01)00880304476103(17)220621(10)670640,  (01)00880304476103(17)220606(10)728190,  (01)00880304476103(17)220512(10)984070,  (01)00880304476103(17)220607(10)984080
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution. US nationwide, Argentina, Australia, Canada, Costa Rica, Japan, and Netherlands.
  • 제품 설명
    Ziptight Ankle Syndesmosis Fixation - Ti, Item # 904759 orthopedic fixation device
  • 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