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-1164-2016
  • 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=143893
  • 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.: 61983708 62030926 62033221 62036882 62036883 62038355 62075338 62075339 62075340 62097036 62097037 62122103 62122104 62154556 62166260 62171392 62171393 62177323 62178289 62181449 62183156 62183157 62188303 62189403 62192487 62193425 62195517 62204536 62206537 62210448 62216685 62222761 62240269 62240270 62240788 62240789 62240790 62240791 62279094 62280474 62284491 62299105 62312497 62312498 62314646 62315889 62317930 62318766 62320172 62324102 62326110 62346579 62354651 61809115 61820812 61911428 62018462 62027424 62028727 62028729 62042580 62042581 62050972 62050973 62050974 62166258 62166259 62167379 62167380 62174631 62174632 62178288 62181453 62186369 62186370 62186371 62194586 62199409 62204537 62210449 62222760 62234477 62234482 62240279 62240792 62240793 62251959 62252977 62252978 62255125 62280475 62284492 62284493 62306522 62306523 62317924 62317925 62317926 62320174 62326111 62332042 62332043 62340067 62340069 62352843 62043467 62075347 62079948 62106810 62128843 62166265 62167376 62188299 62194587 62218121 62240805 62263240 62263242 62301430 62325577 62340074 62344687 61864106 61871776 61891283 61983710 62019782 62036879 62036881 62038359 62043464 62043471 62043472 62046504 62075341 62097039 62097040 62125319 62125321 62166262 62171394 62171395 62171398 62174635 62177326 62181450 62186372 62188304 62189404 62193423 62193424 62199407 62199408 62210451 62215708 62216684 62222759 62240272 62240273 62240281 62240794 62240795 62240796 62263233 62263235 62266495 62278254 62278256 62280476 62284494 62299103 62299104 62311636 62311638 62316417 62316419 62317917 62317927 62320173 62330773 62330774 62332039 62340071 62354649 62362850 61846958 61955607 62038363 62075348 62097043 62106811 62156147 62188301 62194585 62199411 62240806 62282925 62291136 62301431 62325578 61817995 61839052 61839054 61878457 61883398 61883399 61883401 61922364 61983714 62028722 62043465 62046497 62075342 62075343 62075344 62106812 62106813 62109961 62109962 62114840 62119001 62146769 62166264 62167382 62174633 62177327 62178290 62188305 62189405 62192486 62205496 62206535 62206536 62218118 62222416 62227053 62234478 62234484 62240274 62240275 62240797 62240798 62240799 62240801 62264276 62264277 62280477 62284495 62284496 62301429 62306524 62306525 62311640 62332040 62332041 62332087 62339634 62340065 62340066 62345399 62354654 62043468 62080015 62167377 62199410 62251963 62314469 62340076 62354658 370874 62014199 62017581 62028725 62038360 62087362 62087363 62092962 62100681 62114837 62114839 62118999 62167381 62178697 62178698 62181451 62192489 62218119 62221009 62222417 62222762 62234481 62240277 62240803 62263237 62263238 62281834 62282923 62311639 62320175 62332045 62333984 62346580 62352844 62354653 62028731 62079949 62092961 62188302 62227052 62251964 62326109 370865 61870236 61943378 62018464 62043466 62075345 62075346 62114838 62137235 62171396 62171397 62193422 62199406 62222418 62238086 62268569 62281835 62282924 62314642 62320176 62332044 62333985 62333986 62354657 370864 62178699 62181454 62326113 62344689 370862 61957392 62018465 62092964 62109963 62133236 62181452 62211846 62227054 62251961 62301427 62317923 62339635 62339636 62112178 62165195 62203970 62251966 62290198 62203966 62035452 62165196 62361916 62023151 62156144 62203971 62361917 62165197 62203575
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Product 66 consists of all product under product code: JDI and same usage: || Item no: || 785001100 VERSYS ADVOCATE CEMENTED || 785001200 VERSYS ADVOCATE CEMENTED || 785001220 VERSYS ADVOCATE CEMENTED || 785001300 VERSYS ADVOCATE CEMENTED || 785001320 VERSYS ADVOCATE CEMENTED || 785001400 VERSYS ADVOCATE CEMENTED || 785001420 VERSYS ADVOCATE CEMENTED || 785001500 VERSYS ADVOCATE CEMENTED || 785001520 VERSYS ADVOCATE CEMENTED || 785001600 VERSYS ADVOCATE CEMENTED || 785001620 VERSYS ADVOCATE CEMENTED || 785001700 VERSYS ADVOCATE CEMENTED || 785001305 VERSYS ADVOCATE V-LIGN CE || 785001325 VERSYS ADVOCATE V-LIGN CE || 785001405 VERSYS ADVOCATE V-LIGN CE || 785001505 VERSYS ADVOCATE V-LIGN CE || 785001525 VERSYS ADVOCATE V-LIGN CE || 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