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-1147-2016
  • 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=143759
  • 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)
    lot no.: 61901117 61901118 61905924 61907317 61919774 61925086 61925087 61932224 61932230 61976473 61999384 61999385 61999386 61999389 61999392 61999397 61999398 62027343 62034454 62060787 62074474 62074475 62096756 62124173 62124175 62124176 62126603 62126604 62132121 62164944 62168501 62168504 62168505 62168506 62168507 62168509 62168510 62168511 62168512 62174922 62174923 62220941 62227159 62227166 62249275 62258601 62258607 62258618 62258623 62299435 62299436 62299440 62318771 62326940 62337816 62345677 62345678 62345679 62345680 62346195 62358017 62358018 62358019 62362896 62362897 62362898 62362899 62362900 62362902 62379320 62379321 62379322 62379323 62382825 62382827 62382828 62382829 62382830 62382831 62382832 62382833 62382834 62389197 62389199 62394741 62394742 62394743 62394744 62401077 62401079 62401890 62401892 61823947 61823948 61881528 61881531 61881532 61885110 61895826 61901109 61903389 61903390 61905927 61915687 61915688 61919777 61919778 61932241 61941690 61956251 61956252 61956253 61963006 61963010 61963011 61976477 61980333 61985178 61985180 61985181 61985183 61985184 61985186 61985187 61988469 61988474 61988475 61988476 61988478 61988479 61988483 61988484 61999434 61999435 61999436 61999437 61999438 61999441 62017865 62017866 62017867 62017870 62017871 62034471 62034472 62034474 62034480 62060790 62081115 62081128 62093754 62093758 62109782 62118612 62118614 62121748 62121751 62160772 62160780 62164931 62174918 62174919 62180204 62180205 62209028 62213330 62220924 62220927 62220936 62227148 62227150 62227153 62255832 62255836 62255838 62258568 62258569 62258570 62326932 62326937 62337794 62337799 62345664 62345665 62345666 62345669 62345670 62345671 62345672 62352427 62352428 62352429 62352430 62352432 62352434 62358010 62358011 62358012 62358013 62358014 62358015 62358016 62362882 62362883 62362884 62362885 62362886 62362887 62362888 62362889 62379317 62379318 62379319 62387312 62389187 62389188 62389189 62389190 62394734 62394736 62394738 62394739 62394740 62401069 62401070 62401073 62401075 62401883 62401884 62401885 61781515 61869481 61869484 61869485 61903392 61903393 61932247 61932250 61935545 61935546 61935548 61947286 61956258 61963016 61981211 61981212 61981213 61985190 61985191 61985192 61985193 61985195 61988486 61988487 61988489 61988491 61988492 61988497 61988498 61988502 61988503 61988504 61992789 61992791 61992794 61992795 61992796 61992797 61992798 62034484 62064021 62064022 62069747 62069748 62069750 62074482 62111798 62118605 62118607 62122984 62157027 62162239 62162266 62180196 62180197 62180198 62188999 62192592 62197270 62268038 62293115 62318785 62332723 62332724 62358021 62358022 62358023 62358024 62358025 62362905 62362906 62362907 62378347 62378349 62379312 62379313 62379314 62379315 62379316 62383576 62383588 62383589 62383591 62383592 62383593 62389192 62389193 62389194 62389195 62389196 62394749 62394750 62394751 62394752 62394753 62394754 62401083 62401085 61882936 61882938 61895692 61947292 61976480 61976482 61981214 61981215 61981216 61981217 61981218 61981220 61999444 62034502 62034503 62034504 62037965 62038971 62074496 62192217 62197258 62203951 62204541 62253048 62253049 62263581 62263587 62263588 62293118 62293119 62293128 62318780 62318781 62352437 62352438 62352439 62352441 62352442 62374394 62389202 62394745 62394746 62394747 62401004 62401005 62401893 62401894 61914165 61935552 61935554 61935555 61947294 61956264 61981221 61981222 61999447 62027360 62164925 62213298 62268047 62277324 62277325 62306250 61921555 61964050 62319375 62319375N 61878332 61908466 61964051 61977334 61977336 61977338 61977339 62021303 62198811 62213151 62268995 62319370 62319370N 61964053 62285157 62285157N 62268789 62268789N 62291953 61810663 61954695 62286126 62318704 62318704N 61962009 62285185 61985005 62211519 62211520 62255326 62291961 61824622 61889263 61962013 62117886 62211523 62268796 62312072 62025120 62211526 62211527 62268801 62279236 62279236N 62275624 62275624N 62171649 61946653 61946654 62160906 62298657 62401088 62401088R 61885105 62394763 62401087 62394763R 62401087R 61956246 62160899 62379309 62394759 62401090 62394759R 62401090R 62379310 62394760 62379310R 62394760R
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Product 49 consists of all product under product code: JWH and same usage: || Item no: || 597206529 NEXGEN ALL-POLY PATELLA, || 597206532 NEXGEN ALL-POLY PATELLA, || 597206535 NEXGEN ALL-POLY PATELLA, || 597206538 NEXGEN ALL-POLY PATELLA, || 597206541 NEXGEN ALL-POLY PATELLA, || 598801713 NEXGEN CEMENTED STEM EXT || 598801813 NEXGEN CEMENTED STEM EXT || 598801913 NEXGEN CEMENTED STEM EXT || 598801610 NEXGEN FLUTED STEM EXT, 1 || 598801611 NEXGEN FLUTED STEM EXT, 1 || 598801612 NEXGEN FLUTED STEM EXT, 1 || 598801613 NEXGEN FLUTED STEM EXT, 1 || 598801614 NEXGEN FLUTED STEM EXT, 1 || 598801615 NEXGEN FLUTED STEM EXT, 1 || 598801616 NEXGEN FLUTED STEM EXT, 1 || 598801618 NEXGEN FLUTED STEM EXT, 1 || 598801619 NEXGEN FLUTED STEM EXT, 1 || 598801620 NEXGEN FLUTED STEM EXT, 2 || 598801622 NEXGEN FLUTED STEM EXT, 2 || 598801624 NEXGEN FLUTED STEM EXT, 2 || 597206126 NEXGEN MICRO ALL-POLY PAT || 597206129 NEXGEN MICRO ALL-POLY PAT || 597206132 NEXGEN MICRO ALL-POLY PAT || 597206135 NEXGEN MICRO ALL-POLY PAT || 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