Events

Device Recall Zimmer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer Manufacturing B.V. 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
    72900
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1151-2016
  • 사례 시작날짜
    2016-01-11
  • 사례 출판 날짜
    2016-03-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143878
  • 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, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • 원인
    As a result of the insufficient sealer calibration data for product packaged in firm's building ii between august 2010 and april 2013. the affected products are sterile.
  • 조치
    Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.

Device

Device Recall Zimmer
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Product 53 consists of all product under: product code: JWH and same usage: || Item no: || 597002501 NEXGEN PRECOAT PEG TIB PL || 597002502 NEXGEN PRECOAT PEG TIB PL || 597003501 NEXGEN PRECOAT PEG TIB PL || 597003502 NEXGEN PRECOAT PEG TIB PL || 597004501 NEXGEN PRECOAT PEG TIB PL || 597004502 NEXGEN PRECOAT PEG TIB PL || 597005501 NEXGEN PRECOAT PEG TIB PL || 597005502 NEXGEN PRECOAT PEG TIB PL || 597005503 NEXGEN PRECOAT PEG TIB PL || 597005504 NEXGEN PRECOAT PEG TIB PL || 598002701 NEXGEN PRECOAT STEMMED TI || 598002702 NEXGEN PRECOAT STEMMED TI || 598003701 NEXGEN PRECOAT STEMMED TI || 598003702 NEXGEN PRECOAT STEMMED TI || 598004701 NEXGEN PRECOAT STEMMED TI || 598004702 NEXGEN PRECOAT STEMMED TI || 598005701 NEXGEN PRECOAT STEMMED TI || 598005702 NEXGEN PRECOAT STEMMED TI || 598005703 NEXGEN PRECOAT STEMMED TI || 598005704 NEXGEN PRECOAT STEMMED TI || 598801510 NEXGEN SHARP FLUTED STEM || 598801511 NEXGEN SHARP FLUTED STEM || 598801512 NEXGEN SHARP FLUTED STEM || 598801513 NEXGEN SHARP FLUTED STEM || 598801514 NEXGEN SHARP FLUTED STEM || 598801515 NEXGEN SHARP FLUTED STEM || 598801516 NEXGEN SHARP FLUTED STEM || 598801517 NEXGEN SHARP FLUTED STEM || 598801518 NEXGEN SHARP FLUTED STEM || 598801519 NEXGEN SHARP FLUTED STEM || 598801520 NEXGEN SHARP FLUTED STEM || 598801010 NEXGEN STRAIGHT STEM EXT || 598801011 NEXGEN STRAIGHT STEM EXT || 598801012 NEXGEN STRAIGHT STEM EXT || 598801013 NEXGEN STRAIGHT STEM EXT || 598801014 NEXGEN STRAIGHT STEM EXT || 598801015 NEXGEN STRAIGHT STEM EXT || 598801016 NEXGEN STRAIGHT STEM EXT || 598801017 NEXGEN STRAIGHT STEM EXT || 598801018 NEXGEN STRAIGHT STEM EXT || 598801020 NEXGEN STRAIGHT STEM EXT || 598801022 NEXGEN STRAIGHT STEM EXT || 598801024 NEXGEN STRAIGHT STEM EXT || 598801112 NEXGEN STRAIGHT STEM EXT || 598801113 NEXGEN STRAIGHT STEM EXT || 598801114 NEXGEN STRAIGHT STEM EXT || 598801115 NEXGEN STRAIGHT STEM EXT || 598801116 NEXGEN STRAIGHT STEM EXT || 598801117 NEXGEN STRAIGHT STEM EXT || 598801118 NEXGEN STRAIGHT STEM EXT || 598801212 NEXGEN STRAIGHT STEM EXT || 598801215 NEXGEN STRAIGHT STEM EXT || for use in total knee arthroplasty
  • Manufacturer
    Zimmer Manufacturing B.V.

Manufacturer

Zimmer Manufacturing B.V.
  • 제조사 주소
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • 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