Events

Device Recall Persona TASP 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer, 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
    68817
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2297-2014
  • 사례 시작날짜
    2013-06-10
  • 사례 출판 날짜
    2014-08-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-09-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129083
  • 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
    Zimmer had received complaints that reported breakage of the persona knee trial articular surface provisionals (tasps). this is a retrospective recall which covers zimmer's corrective actions taken earlier this year concerning the tasps.
  • 조치
    On February 10, 2014, Zimmer sent letter to surgeons who had filed complaints regarding the affected TASP fractures. The letter provided the surgeons with Zimmer's investigational findings of the issue. Surgeons were directed to send questions or any additional informtion to Zimmer.PER@Zimmer.com. The Zimmer Weekly Wrap-Up, dated February 14, 2014, was issued electronically to sales force. They were notified to engage in mandatory training to improve the usage of the TASPs and prevent potential breakage. Zimmer has taken additional corrective measures by initiating another recall in July 2014 whereby they notify the distributors as well as all users of the enhanced surgical technique.

Device

Device Recall Persona TASP
  • 모델명 / 제조번호(시리얼번호)
    Item Numbers: 42517000303 42517000313 42517000505 42517000515 42517000707 42517000717 42517000909 42517000919 42527000303 42527000313 42527000505 42527000515 42527000707 42527000717 42527000909 42527000919  Lot Numbers:  62022340 62024973 62062232 62104367 62187314 62187315 62190367 62190370 62265725 62301862 62314675 62385126 62385132 62355857 62403987 62414017 62420244 62456269 62506026 62506044 62531664 62558106 62564325 62596552 62600208 62614790 62683419 62691385 62698730 62716777 62024974 62032099 62075271 62144791 62171682 62171684 62184223 62187317 62239237 62256256 62248153 62386757 62391108 62414001 62391109 62414002 62456271 62474902 62544384 62565107 62565106 62601564 62612269 62627270 62678888 62684675 62695301 62710627 62745014 62019862 62091183 62177238 62177239 62177240 62268818 62282708 62305406 62314683 62351287 62356123 62385455 62401419 62405946 62419059 62429198 62456279 62504887 62531665 62559945 62565049 62595861 62621822 62627202 62663169 62690886 62696853 62698724 62716769 62710616 62030854 62050136 62125572 62154284 62165540 62168382 62177242 62190375 62247344 62247345 62256257 62364951 62391110 62413998 62391111 62427064 62413999 62469454 62525495 62538399 62565110 62565111 62565109 62595858 62630285 62632817 62680122 62680123 62691389 62696886 62710624 62717356 62022342 62024977 62087042 62091198 62165542 62189343 62187321 62233919 62239239 62256279 62247347 62386756 62391114 62391115 62403989 62419057 62429191 62461234 62525494 62544359 62564327 62587605 62601573 62601574 62668825 62696851 62717321 62744886 62747704 62030862 62029578 62125573 62165544 62189323 62189322 62189324 62201539 62239240 62256280 62247349 62372408 62386777 62391226 62403995 62420263 62456272 62506051 62544380 62565113 62565114 62595867 62663132 62668575 62691387 62689234 62717344 62338672 62338673 62338674 62338675 62504658 62511928 62564328 62619534 62383954 62427416 62443506 62495522 62498723 62669167 62710621 62055685 62075277 62149177 62192902 62192903 62198204 62233922 62305408 62356554 62385133 62385134 62404280 62420241 62449201 62515528 62529691 62551363 62564308 62604993 62614838 62616391 62683416 62715142 62715143 62724729 62732162 62043562 62104420 62166222 62196582 62196583 62196584 62233923 62305409 62356575 62356576 62386778 62404281 62427063 62419055 62449190 62497269 62544355 62565097 62565098 62600182 62595870 62608888 62677155 62678897 62696859 62710617 62730175 62043563 62091814 62177255 62188407 62188408 62188409 62233924 62305410 62356580 62356582 62386427 62429080 62429081 62442784 62479530 62480204 62480205 62544357 62544358 62568264 62569954 62592280 62595862 62611084 62641326 62654924 62695307 62710625 62740696 62036671 62125597 62144797 62203401 62203402 62209047 62229714 62239297 62248169 62315063 62356591 62364962 62386780 62391235 62419058 62442845 62469460 62531658 62551097 62568294 62654893 62654894 62663171 62683434 62702755 62055687 62089764 62189328 62209048 62229720 62239303 62290779 62311023 62351301 62315137 62356596 62386781 62391238 62404283 62420245 62449209 62504870 62544366 62565096 62581866 62597790 62608891 62612281 62683418 62686270 62724731 62724732 62046410 62125598 62149716 62187330 62187331 62239305 62239306 62248170 62320808 62356601 62385135 62385136 62404284 62420257 62449213 62504874 62529692 62558587 62581868 62600187 62608890 62627268 62684651 62689233 62690894 62702304 62702306 62710622 62394886 62400296 62428415 62443507 62500932 62500933 62551242 62597759 62660204 62646280 62380844 62399812 62428395 62443504 62493131 62536079 62564309 62632816 62695868
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore.
  • 제품 설명
    Persona (TM) The Personalized Knee System || Tibial Articular Surface Provisional Bottom || Nonsterile || TASP L CD BOTTOM, +0MM || TASP L CD BOTTOM, +6MM || TASP L EF BOTTOM, +0MM || TASP L EF BOTTOM, +6MM || TASP L GH BOTTOM, +0MM || TASP L GH BOTTOM, +6MM || TASP L J BOTTOM, +0MM || TASP L J BOTTOM, +6MM || TASP R CD BOTTOM, +0MM || TASP R CD BOTTOM, +6MM || TASP R EF BOTTOM, +0MM || TASP R EF BOTTOM, +6MM || TASP R GH BOTTOM, +0MM || TASP R GH BOTTOM, +6MM || TASP R J BOTTOM, +0MM || TASP R J BOTTOM, +6MM
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • 제조사 주소
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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