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-1955-2016
  • 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=145922
  • 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
    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)
    00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 61868161 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 62075682 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 61868174 00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM 62099999 00720505228 ACETAB.CUPW/SH,0DEG,28MMX52MM 61985379 00720505628 ACETAB.CUPW/SH,0DEG,28MMX56MM 61739647 00720505828 ACETAB.CUPW/SH,0DEG,28MMX58MM 61859335 00720506028 ACETAB.CUPW/SH,0DEG,28MMX60MM 61868180 00720506228 ACETAB.CUPW/SH,0DEG,28MMX62MM 61885454 61912432 00720506428 ACETAB.CUPW/SH,0DEG,28MMX64MM 61763307 00721004222 ACETAB.CUPW/SH,10DEG,22MMX42MM 62075683 00721004422 ACETAB.CUPW/SH,10DEG,22MMX44MM 61792574 00721005028 ACETAB.CUPW/SH,10DEG,28MMX50MM 61747148 61770547 61859658 00721005228 ACETAB.CUPW/SH,10DEG,28MMX52MM 61747106 61812211 61830726 00721005628 ACETAB.CUPW/SH,10DEG,28MMX56MM 62020209 00721006428 ACETAB.CUPW/SH,10DEG,28MMX64MM 61836505 61855146 61954911 00721006628 ACETAB.CUPW/SH,10DEG,28MMX66MM 61830949 00721006828 ACETAB.CUPW/SH,10DEG,28MMX68MM 61885408 00721007028 ACETAB.CUPW/SH,10DEG,28MMX70MM 61830844 61859307 00725504222 ACETAB.CUP, 0 DEG, 22MM X 42MM 61770545 61804351 61763316 61786342 61786341 61804383 00725504622 ACETAB.CUP, 0 DEG, 22MM X 46MM 61770407 61804495 00725504626 ACETAB.CUP, 0 DEG, 26MM X 46MM 61836909 00725504828 ACETAB.CUP, 0 DEG, 28MM X 48MM 61947556 00725505232 ACETAB.CUP, 0 DEG, 32MM X 52MM 61747107 61763580 61786278 61830727 61859504 61859551 61879091 61879090 61912430 62002120 62075898 62100011 62115299 00725505432 ACET CUP, 0 DEG, 32MM X 54MM 61763443 61786289 61812220 61854565 61868305 61879040 61912416 61947555 61985264 62013146 62066591 62115776 00725505632 ACET CUP, 0 DEG, 32MM X 56MM 61763600 61804444 61912435 62002156 62039255 62062844 62062845 62115784 00725505828 ACETAB.CUP, 0 DEG, 28MM X 58MM 61804502 61837084 00725505832 ACET CUP, 0 DEG, 32MM X 58MM 62039086 00725506028 ACETAB.CUP, 0 DEG, 28MM X 60MM 61855145 00725506032 ACET CUP, 0 DEG, 32MM X 60MM 62075897 62100842 00725506228 ACETAB.CUP, 0 DEG, 28MM X 62MM 61770404 00725506232 ACET CUP, 0 DEG, 32MM X 62MM 62087671 62087672 62100008 00725506428 ACETAB.CUP, 0 DEG, 28MM X 64MM 61804463 61854444 00725506432 ACET CUP, 0 DEG, 32MM X 64MM 62075673 00725506628 ACETAB.CUP, 0 DEG, 28MM X 66MM 61885383 00725506632 ACET CUP, 0 DEG, 32MM X 66MM 62075875 62100005 00725506828 ACETAB.CUP, 0 DEG, 28MM X 68MM 61885410 00725506832 ACET CUP, 0 DEG, 32MM X 68MM 62091779 00725507028 ACETAB.CUP, 0 DEG, 28MM X 70MM 61830845 61859308 00725507032 ACET CUP, 0 DEG, 32MM X 70MM 62075857 00726004222 ACETAB.CUP,10 DEG, 22MM X 42MM 61804352 61812219 61786434 61804386 61763388 00726004828 ACETAB.CUP,10 DEG, 28MM X 48MM 61854356 61860438 61868209 62008764 00726005028 ACETAB.CUP,10 DEG, 28MM X 50MM 61747062 61804506 61859667 61878894 61947703 61976855 62002987 62039360 62063078 00726005228 ACETAB.CUP,10 DEG, 28MM X 52MM 61964956 62064122 62087681 62115304 00726005232 ACETAB.CUP,10 DEG, 32MM X 52MM 61747120 61763581 61786280 61792602 61879104 61912431 61947575 61985342 62002123 62008989 62039411 62075899 62062910 62087682 62100014 62115305 00726005432 ACET CUP, 10 DEG, 32MM X 54MM 61747076 61763450 61786291 61860512 61912417 61947554 61955257 61976866 61985266 62013145 62066592 62066593 62115775 62115774 00726005632 ACET CUP, 10 DEG, 32MM X 56MM 61786224 61854602 61860631 61912436 61976925 61976926 62002157 62009002 62020437 62063038 62115785 00726005832 ACET CUP, 10 DEG, 32MM X 58MM 62002962 62008999 62020376 62116069 00726006032 ACET CUP, 10 DEG, 32MM X 60MM 61912429 61985228 62002828 62008790 62054549  00726006428 ACETAB.CUP,10 DEG, 28MM X 64MM 61762694 61860439 61860486 61885485 61947469 61976880 00726006432 ACET CUP, 10 DEG, 32MM X 64MM 62020184  00726006628 ACETAB.CUP,10 DEG, 28MM X 66MM 61762674 61854537 00726006632 ACET CUP, 10 DEG, 32MM X 66MM 62020226 62100007 00726006828 ACETAB.CUP,10 DEG, 28MM X 68MM 61885411 62075884 00726006832 ACET CUP, 10 DEG, 32MM X 68MM 62095411 00726007028 ACETAB.CUP,10 DEG, 28MM X 70MM 61831011 61859310 61946201 00726007032 ACET CUP, 10 DEG, 32MM X 70MM 61976770
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide and Foreign.
  • 제품 설명
    00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM || 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM || 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM || 00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM || 00720505228 ACETAB.CUPW/SH,0DEG,28MMX52MM || 00720505628 ACETAB.CUPW/SH,0DEG,28MMX56MM || 00720505828 ACETAB.CUPW/SH,0DEG,28MMX58MM || 00720506028 ACETAB.CUPW/SH,0DEG,28MMX60MM || 00720506228 ACETAB.CUPW/SH,0DEG,28MMX62MM || 00720506428 ACETAB.CUPW/SH,0DEG,28MMX64MM || 00721004222 ACETAB.CUPW/SH,10DEG,22MMX42MM || 00721004422 ACETAB.CUPW/SH,10DEG,22MMX44MM || 00721005028 ACETAB.CUPW/SH,10DEG,28MMX50MM || 00721005228 ACETAB.CUPW/SH,10DEG,28MMX52MM || 00721005628 ACETAB.CUPW/SH,10DEG,28MMX56MM || 00721006428 ACETAB.CUPW/SH,10DEG,28MMX64MM || 00721006628 ACETAB.CUPW/SH,10DEG,28MMX66MM || 00721006828 ACETAB.CUPW/SH,10DEG,28MMX68MM || 00721007028 ACETAB.CUPW/SH,10DEG,28MMX70MM || 00725504222 ACETAB.CUP, 0 DEG, 22MM X 42MM || 00725504622 ACETAB.CUP, 0 DEG, 22MM X 46MM || 00725504626 ACETAB.CUP, 0 DEG, 26MM X 46MM || 00725504828 ACETAB.CUP, 0 DEG, 28MM X 48MM || 00725505232 ACETAB.CUP, 0 DEG, 32MM X 52MM || 00725505432 ACET CUP, 0 DEG, 32MM X 54MM || 00725505632 ACET CUP, 0 DEG, 32MM X 56MM || 00725505828 ACETAB.CUP, 0 DEG, 28MM X 58MM || 00725505832 ACET CUP, 0 DEG, 32MM X 58MM || 00725506028 ACETAB.CUP, 0 DEG, 28MM X 60MM || 00725506032 ACET CUP, 0 DEG, 32MM X 60MM || 00725506228 ACETAB.CUP, 0 DEG, 28MM X 62MM || 00725506232 ACET CUP, 0 DEG, 32MM X 62MM || 00725506428 ACETAB.CUP, 0 DEG, 28MM X 64MM || 00725506432 ACET CUP, 0 DEG, 32MM X 64MM || 00725506628 ACETAB.CUP, 0 DEG, 28MM X 66MM || 00725506632 ACET CUP, 0 DEG, 32MM X 66MM || 00725506828 ACETAB.CUP, 0 DEG, 28MM X 68MM || 00725506832 ACET CUP, 0 DEG, 32MM X 68MM || 00725507028 ACETAB.CUP, 0 DEG, 28MM X 70MM || 00725507032 ACET CUP, 0 DEG, 32MM X 70MM || 00726004222 ACETAB.CUP,10 DEG, 22MM X 42MM || 00726004828 ACETAB.CUP,10 DEG, 28MM X 48MM || 00726005028 ACETAB.CUP,10 DEG, 28MM X 50MM || 00726005228 ACETAB.CUP,10 DEG, 28MM X 52MM || 00726005232 ACETAB.CUP,10 DEG, 32MM X 52MM || 00726005432 ACET CUP, 10 DEG, 32MM X 54MM || 00726005632 ACET CUP, 10 DEG, 32MM X 56MM || 00726005832 ACET CUP, 10 DEG, 32MM X 58MM || 00726006032 ACET CUP, 10 DEG, 32MM X 60MM || 00726006428 ACETAB.CUP,10 DEG, 28MM X 64MM || 00726006432 ACET CUP, 10 DEG, 32MM X 64MM || 00726006628 ACETAB.CUP,10 DEG, 28MM X 66MM || 00726006632 ACET CUP, 10 DEG, 32MM X 66MM || 00726006828 ACETAB.CUP,10 DEG, 28MM X 68MM || 00726006832 ACET CUP, 10 DEG, 32MM X 68MM || 00726007028 ACETAB.CUP,10 DEG, 28MM X 70MM || 00726007032 ACET CUP, 10 DEG, 32MM X 70MM
  • 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