Events

Device Recall BETA HIP PROSTHESIS 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer Biomet, 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
    73142
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0849-2016
  • 사례 시작날짜
    2016-01-11
  • 사례 출판 날짜
    2016-02-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143461
  • 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, porous uncemented - Product Code LPH
  • 원인
    Ldpe bag containing the implant adheres to the highly polished implant surface.
  • 조치
    Zimmer Biomet sent an Urgent Medical Device Recall dated January 11, 2016, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers with questions or concerns were instructed to contact customer service at 1-800-348-2759 or contact their Zimmer Biomet Sales Representative. For questions regarding this recall call 800-447-5633.

Device

Device Recall BETA HIP PROSTHESIS
  • 모델명 / 제조번호(시리얼번호)
    Item numbers: 00-7843-011-06 00-7843-011-08 00-7843-011-36 00-7843-012-06 00-7843-012-08 00-7843-012-36 00-7843-013-06 00-7843-013-08 00-7843-013-36 00-7843-014-06 00-7843-014-08 00-7843-014-36 00-7843-015-06 00-7843-015-08 00-7843-015-36 00-7843-016-06 00-7843-016-08 00-7843-016-36 00-7843-017-06 00-7843-017-08 00-7843-017-36 00-7843-018-06 00-7843-018-08 00-7843-018-36 00-7843-019-06 00-7843-019-36 00-7843-020-06 00-7843-020-08 00-7843-020-36 00-7843-021-06 00-7843-021-36 00-7843-022-06 00-7843-022-36 Lot numbers: 11003968 11003975 11004089 11004219 11004274 11004333 11004746 11005067 11005118 11008034 61669552 61669554 61669559 61669561 61669563 61695978 61699465 61704396 61704397 61714436 61721717 61721719 61721720 61729915 61729916 61729917 61729919 61735802 61735816 61735817 61735818 61741801 61741802 61741815 61746858 61746859 61746860 61746875 61746876 61746878 61746888 61746890 61746892 61752717 61752718 61752719 61752722 61752738 61752739 61752740 61759256 61759257 61759271 61759272 61759273 61759274 61759275 61759276 61768675 61768676 61768677 61768689 61768690 61768691 61768692 61768693 61768695 61768696 61768697 61768698 61768699 61775242 61775243 61775251 61775252 61775253 61775254 61781978 61781998 61781999 61782001 61782002 61786858 61786866 61786867 61792530 61792544 61792545 61792546 61792547 61792561 61797304 61797305 61797306 61797307 61797308 61797309 61797310 61797311 61797312 61797314 61797315 61797316 61797317 61797318 61797319 61797320 61797321 61797322 61797323 61803226 61803227 61803229 61803230 61803231 61803233 61807094 61807095 61807106 61807107 61807108 61807109 61807110 61807111 61807112 61807113 61807114 61813331 61813332 61813336 61813345 61813352 61813353 61813356 61813363 61813364 61813367 61813369 61813370 61813371 61813372 61813373 61813374 61814011 61814012 61814013 61814014 61814015 61814016 61814017 61814018 61814019 61814020 61814021 61814022 61814023 61815074 61815075 61815077 61815078 61815096 61815098 61829335 61829338 61829339 61829341 61829343 61829349 61829351 61829370 61829371 61829372 61829374 61829375 61834813 61834815 61834822 61834823 61834824 61834827 61834830 61834831 61840205 61840209 61840221 61840224 61840227 61840232 61840233 61840234 61840238 61840242 61840251 61840252 61844728 61844729 61844730 61844731 61844732 61844733 61844734 61844738 61844739 61844740 61844744 61848231 61848232 61848233 61848235 61848237 61848240 61848241 61848242 61848244 61848245 61848246 61848247 61848250 61848251 61852807 61852808 61852809 61852812 61852813 61852814 61852815 61852816 61852819 61852822 61852825 61852826 61852827 61852828 61872116 61872117 61872118 61872120 61872122 61872123 61872126 61876835 61876836 61876839 61876840 61876842 61876843 61876844 61876845 61876847 61876848 61876858 61879445 61879447 61879449 61879451 61879461 61886029 61886030 61886032 61886033 61886039 61886045 61886047 61890372 61890373 61890374 61890375 61890376 61890377 61890378 61890379 61890380 61890383 61894503 61894505 61894508 61894510 61894511 61894514 61902381 61910054 61915336 61915337 61915338 61915339 61915340 61915341 61915344 61915346 61917982 61920851 61920852 61920853 61920854 61920855 61920856 61920861 61920864 61920908 61920909 61925413 61925414 61925417 61925419 61925421 61925422 61925424 61925425 61925426 61925427 61925428 61925429 61925435 61932606 61932607 61932608 61932612 61932613 61937666 61937667 61937668 61937674 61937675 61937677 61941398 61941399 61941400 61941401 61941402 61941403 61941405 61941406 61941407 61946013 61946015 61946019 61946020 61946021 61946022 61946023 61946024 61951267 61951268 61951269 61951274 61951277 61951280 61956719 61956720 61956721 61956727 61963714 61963716 61963717 61963718 61963720 61963721 61963723 61963725 61968099 61968100 61968104 61968106 61968107 61968110 61974950 61974952 61974955 61974957 61974965 61974967 61974968 61974969 61981779 61981790 61981814 61981815 61987935 61993634 61993636 61993638 61993639 61993641 61993646 62003664 62003665 62003666 62003668 62003669 62003674 62006749 62006766 62006767 62006768 62006769 62006770 62006771 62006772 62006773 62006774 62006775 62006776 62006777 62006780 62006781 62011949 62011956 62011957 62011960 62011963 62011964 62011966 62011968 62020331 62020332 62020333 62020334 62020335 62020336 62020337 62020338 62020339 62020343 62020344 62020345 62025501 62025502 62025510 62025511 62029054 62029058 62029059 62029063 62029066 62034133 62034135 62034143 62034148 62034150 62034164 62043098 62043099 62043101 62043102 62043104 62043105 62043106 62043109 62043112 62045153 62045154 62045155 62045156 62045157 62045158 62045159 62045161 62045162 62045163 62053682 62053683 62053684 62053686 62053688 62053690 62053691 62053693 62054922 62059543 62059544 62059545 62059546 62059549 62059687 62067438 62067439 62067445 62067447 62067448 62067449 62067451 62067452 62067453 62067454 62071746 62071747 62071748 62071749 62071751 62071753 62071761 62071766 62077671 62077672 62077673 62077674 62077675 62077677 62077678 62077679 62077682 62082537 62082538 62082539 62085289 62085295 62085297 62089490 62089491 62089493 62089496 62089497 62089498 62089501 62089510 62089512 62089515 62097218 62097221 62097228 62097235 62097239 62097240 62102120 62102123 62102124 62107866 62107867 62107868 62107869 62107870 62107871 62107872 62107874 62107876 62116467 62116470 62116478 62116488 62116489 62116491 62116526 62116529 62116538 62120675 62120681 62132177 62132179 62132180 62132181 62132184 62132188 62132190 62132191 62133150 62133151 62135308 62135310 62135313 62135314 62135316 62135319 62143762 62143763 62143766 62143768 62143769 62143771 62147259 62147260 62147262 62147265 62147266 62147270 62153938 62153939 62153940 62153942 62153943 62153944 62153945 62153946 62153948 62153950 62158839 62158848 62158852 62158858 62184773 62184775 62184776 62184779 62184780 62184781 62191770 62191774 62202961 62202962 62202964 62208169 62208171 77000584 77000586 77000587 77000588 77000589 77000591 77000812 77000813 77000815 77000816 77000817 77000818 77000823 77000824 77000825 77000826 77000827 77000828 77000829 77000830 77000991 77000992 77000993 77000995 77000996 77000997 77000998 77000999 77001426 77001430 77001432 77001434 77001542 77001544 77001546 77001548 77001549 77001551 77001558 61752739R
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN REPUBLIC DORAL FL ECUADOR EL SALVADOR ENGLAND FRANCE GERMANY GUATEMALA HONDURAS HONG KONG INDIA ISRAEL ITALY JAMAICA JAPAN KOREA MALAYSIA MEXICO NEW ZEALAND NICARAGUA PANAMA PERU SINGAPORE SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND VENEZUELA WEST INDIES Canary Islands Croatia Cyprus Czech Republic Canada
  • 제품 설명
    VERSYS 6 INCH BEADED FC 1 || VERSYS 6 INCH BEADED FC S || VERSYS 8 INCH BEADED FC 1 || VERSYS 8 INCH BEADED FC 2 || prosthesis, hip, semi-constrained, metal/polymer, porous uncemented || "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. " Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected."
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • 제조사 주소
    Zimmer Biomet, 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