Device Recall VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS

  • 모델명 / 제조번호(시리얼번호)
    Item Number: 00-7843-015-11 Lot Numbers: 62097294 11006832 62116495 61981821 Item Number: 00-7843-015-12 Lot Numbers: 62085294 11004177 62097244 61759259 62133149 61807097 77000821 61963730
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
  • 제품 설명
    VERSYS 10 INCH BEADED FC REV 15.0X250MM BWD LT & RT || VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 제조사 모회사 (2017)
  • 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

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  • 모델명 / 제조번호(시리얼번호)
    Item numbers: 00-7843-012-18 00-7843-013-18 00-7843-015-18 00-7843-015-24 00-7843-016-18 00-7843-016-24 00-7843-018-18 00-7843-018-24 00-7843-019-18 00-7843-019-24 00-7843-021-18 00-7843-021-24 00-7843-022-18 00-7843-022-24 Lot numbers: 11006277 61775244 61781982 61786860 61815081 61879442 61937678 61956718 61956722 61981808 61993659 62029064 62043111 62143772 77000810 77000822
  • 의료기기 분류등급
  • 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 7.5 INCH BEADED FC || 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
  • 모델명 / 제조번호(시리얼번호)
    Item Number: 00-7843-013-18 Lot Number: 62158840
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
  • 제품 설명
    VERSYS 7.5 INCH BEADED FC REV 13.5X190MM STRAIGHT || Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Item Number: 00-7843-012-08 Lot Numbers: 62053685 62116471 Item Number: 00-7843-013-08 Lot Number: 62184774 Item Number: 00-7843-014-08 Lot Numbers: 62184777 62158847 62184778 Item Number: 00-7843-013-81 Lot Numbers: 61987954 61815082 62116484 61956726 Item Number: 00-7843-015-08 Lot Number: 62158851 Item Number: 00-7843-013-82 Lot Numbers: 61937673 61759258 61951276 61815083 62120674 61829373 77000819 Item Number: 00-7843-015-81 Lot Numbers: 61968101 61781981 61968103 Item Number: 00-7843-015-82 Lot Numbers: 61834826 61932605 Item Number: 00-7843-016-81 Lot Numbers: 61735809 61759260 Item Number: 00-7843-016-82 Lot Numbers: 62029071 61775246 62029071N 61981820 77000820
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
  • 제품 설명
    VERSYS 8 INCH BEADED FC || 12X200MM STR STD BODY/NECK || 13X200MM STR STD BODY/NECK || 14X200MM STR STD BODY/NECK || REV 13.5X200MM BWD LT || 15X200MM STR STD BODY/NECK || REV 13.5X200MM BWD RT || REV 15.0X200MM BWD LT || REV 15.0X200MM BWD RT || REV 16.5X200MM BWD LT || REV 16.5X200MM BWD RT || Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  • Manufacturer