Events

Zimmer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer Trabecular Metal Technology, 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
    73536
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1950-2016
  • 사례 시작날짜
    2016-04-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-11-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144426
  • 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, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
  • 원인
    Zimmer biomet is initiating a recall of specific lots of foil pouched, sterile trabecular metal implants that were manufactured between april 2011 and october 2012. the foil pouches are part of a dual barrier system to provide sterile integrity.
  • 조치
    Zimmer issued an Urgent Medical Device Recall Letter dated 4/15/2016.

Device

Zimmer
  • 모델명 / 제조번호(시리얼번호)
    POROUS PATELLA 32MM X 10MM 61728647 61762587 62028703 62082384 61998061 61728648 61781040 62028701 62082387 61998065 61762578 61781037 62028702 62100771 62003279 61762581 61781039 62028705 62100774 62003280 61762584 61796452 62051894 62100773 61998062 61762585 61796458 62051896 62100775 61998064 61770640 61770641 62051895 62100777 62003281 61770642 61796459 62109088 62109087 62003282 61762579 61781036 62109089 62100768 62003283 61762580 61770638 62100770 62100769 62007635 61762582 61781038 62109090 62100772 62007636 61762583 61796451 62119906 62100776 61874756 61770639 61796460 62119907 62109086 61874758 61890052 61910583 61890055 61914846 61878840 61890053 61910584 61890054 61914845 61878841 61890056 61896662 61910581 61830190 61878844 61844395 61890050 61910582 61830189 61890058 61914849 61830191 61844393 62007641 62082386 61914848 61850552 61850551 62022120 62082388 61946320 61874757 61850549 62022121 62082383 61952743 61878842 61850553 62022123 62082379 61977124 61878843 61890057 62028698 62082381 61977125 61762586 61830192 62119909 62119910 61977130 61796453 61834679 62082385 62119908 61977123 61796455 61834680 62007643 61986196 61977129 61796456 61834681 62009518 61998059 61986193 61796454 61834682 62016304 62051893 61986194 61796457 61834683 62007642 62051890 61896664 61807383 61840029 62016301 62051891 61890051 61814825 61840032 62016303 62051892 61896660 61807384 61840031 62007637 62051897 61896661 61814823 61840030 62007640 62051898 61896663 61814824 61840033 62007644 62051899 61910585 61818410 61844394 62016305 62082380 62016306 61844396 62009517 61914847 62082382  POROUS PATELLA 35MM X 10MM  61722891 61722891 61752727 61752729 61752730 61752728 61762601 61770637 61762596 61762603 61762599 61762602 61776851 61776852 61762597 61762604 61781047 61781046 61796468 61776850 61796465 61796466 61776853 61796467 61796464 61796469 61807385 61818413 61807386 61814827 61818412 61807387 61830194 61830202 61830195 61834685 61834684 61834686 61840037 61840039 61844360 61844362 61844361 61840038 61840036 61844359 61849996 61857275 61857276 61857277 61868653 61878845 61868652 61868654 61874759 61874760 61878846 61868651 61874761 61890059 61896671 61896668 61896672 61896667 61896670 61903294 61903295 61914851 61914850 61914852 61946323 61952744 61977126 61977139 61977140 61986199 61986201 61986202 61986203 62003288 62003289 62003286 62003287 61998082 61998085 61998084 61998083 62003284 62003285 62009514 62016485 62007648 62016483 62016484 62007647 62009515 62016482 62022175 62022176 62028735 62034999 62035003 62035002 62028737 62035001 62042101 62042103 62042104 62028741 62042102 62028740 62051906 62051903 62051904 62051905 62091107 62091109 62091106 62096105 62096108 62100779 62100780 62096107 62100781 62096106 62100778 62119905 62119902 62119903 62119904  POROUS PATELLA 38MM X 10MM   61722890 61722890 61728637 61749117 61749116 61752627 61752628 61752629 61762575 61781045 61776847 61781043 61776846 61776848 61781044 61796472 61796471 61807400 61807401 61814828 61830199 61818425 61834690 61834691 61840041 61840042 61844358 61857297 61868679 61857273 61868680 61868681 61890060 61896673 61903297 61910580 61903296 61914853 61946325 61952745 61977127 61977128 61977133 61986208 61986209 62003292 62003290 62003291 61998096 61998094 62022182 62022183 62028754 62051910 62051909 62051911 62051912 62072548 62072549 62091117 62091119 62091118 62100783 62100782 62100784 62082403 62082404 62082405  POROUS PATELLA 41MM X 10MM   61749111 61749111 61749112 61762576 61776843 61796473 61818426 61830201 61840040 61874763 61874762 61903298 61914854 61946326 61952746 61977134 61977135 61986204 62003294 62003293 62022184 62028758 62051913 62072546 62091121 62100785 62082397
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide and Foreign.
  • 제품 설명
    POROUS PATELLA 32MM X 10MM - 00587806532 || POROUS PATELLA 35MM X 10MM- 00587806535 || POROUS PATELLA 38MM X 10MM - 00587806538 || POROUS PATELLA 41MM X 10MM - 00587806541
  • Manufacturer
    Zimmer Trabecular Metal Technology, Inc.

Manufacturer

Zimmer Trabecular Metal Technology, Inc.
  • 제조사 주소
    Zimmer Trabecular Metal Technology, Inc., 10 Pomeroy Rd, Parsippany NJ 07054-3722
  • 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