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-1169-2016
  • 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=143898
  • 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, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
  • 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)
    lot no.: 62141788 62194578 62284482 62284482N 61870886 61885906 61952556 61952557 62024629 62065277 62076884 62097070 62125314 62147327 62167372 62193417 62194579 62221879 62270707 62298289 62310428 62340081 62360302 61886895 61953169 62036899 62046493 62055999 62065278 62097073 62106807 62125315 62127736 62141792 62151830 62167373 62183148 62194580 62208755 62210445 62291930 62310435 62324097 62333971 62340080 62358910 62362926 61881190 61890332 61953170 61964733 62033228 62056001 62073507 62076886 62080036 62080037 62097076 62106804 62137224 62141789 62147328 62151832 62165198 62165199 62178286 62181429 62183150 62204531 62207225 62208757 62210446 62270709 62291929 62310430 62310432 62320165 62333970 62340077 62340078 62345388 62345389 62354664 62358904 62358905 61873652 61882614 61885902 61885904 61891301 61969293 62033229 62042592 62052831 62060680 62097077 62100687 62106802 62106803 62137225 62141790 62165201 62165202 62183149 62203186 62210447 62215710 62227046 62240749 62240750 62291931 62312488 62324096 62333976 62333978 62358908 62358909 61834957 61878471 61952559 61957434 61964735 62017573 62033230 62073508 62076888 62100688 62106805 62133327 62141791 62161482 62181430 62203187 62218181 62240751 62270711 62298290 62325574 62340079 61864115 62033231 62056002 62076889 62106806 62137226 62165203 62194581 62218180 62312489 62340082 62358903
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Product 71 consists of all product under product code: JDI and same usage: || Item no: || 783401000 VERSYS PRESS FIT LD/FX ST || 783401100 VERSYS PRESS FIT LD/FX SZ || 783401200 VERSYS PRESS FIT LD/FX SZ || 783401300 VERSYS PRESS FIT LD/FX SZ || 783401400 VERSYS PRESS FIT LD/FX SZ || 783401500 VERSYS PRESS FIT LD/FX SZ || 783401600 VERSYS PRESS FIT LD/FX SZ || For use in total or hemi hip 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