Events

Device Recall Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant 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
    79105
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0818-2018
  • 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=161383
  • 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
    Ziptight ankle syndesmosis fixation was packaged without the tip protectors.
  • 조치
    Customers were notified via letter on about 08/22/2017. Instructions for distributors, sales representatives, and distributor operation managers include to ensure affected personnel are aware of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return affected product, and identify any additional hospitals or surgeons that should be notified. Instructions for surgeons and risk managers include to ensure affected personnel are aware of the recall, identify and quarantine any affected product on hand, complete and return the Certificate of Acknowledgement, return any affected product. Questions or concerns can be addressed to the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST, Monday through Friday. Additionally, questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com.

Device

Device Recall Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant
  • 모델명 / 제조번호(시리얼번호)
    Item No. 905759, Lot No. (UDI No.): 58860 ((01)00880304476103(17)220523(10)058860), 58880 ((01)00880304476103(17)220608(10)058880), 58890 ((01)00880304476103(17)220608(10)058890), 58910 ((01)00880304476103(17)220608(10)058910), 116030 ((01)00880304476103(17)220519(10)116030), 169780 ((01)00880304476103(17)220609(10)169780), 169790 ((01)00880304476103(17)220608(10)169790), 213450 ((01)00880304476103(17)220609(10)213450), 213480 ((01)00880304476103(17)220607(10)213480), 374420 ((01)00880304476103(17)220319(10)374420), 392530 ((01)00880304476103(17)220610(10)392530), 476670 ((01)00880304476103(17)220607(10)476670), 503830 ((01)00880304476103(17)220608(10)503830), 614910 ((01)00880304476103(17)220421(10)614910), 670640((01)00880304476103(17)220621(10)670640), 728190 ((01)00880304476103(17)220606(10)728190), 984070 ((01)00880304476103(17)220512(10)984070), 984080 ((01)00880304476103(17)220607(10)984080)
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distributed domestically to AK, AL, AR, AZ, CA, CO, FL, ID, IN, KY, MA, MD, ME, MI, MN, MO, NC, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI. Distributed internationally to ARGENTINA, AUSTRALIA, CANADA, COSTA RICA, JAPAN, NETHERLANDS.
  • 제품 설명
    Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.
  • 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