Device Recall ATN System

  • 모델명 / 제조번호(시리얼번호)
    915209320 915209340 915209360 915209380 915209400 915209420 915209440 915209460 915211320 915211340 915211360 915211380 915211400 915211420 915211440 915211460 915213320 915213340 915213360 915213380 915213400 915213420 915213440 915213460 916209320 916209340 916209360 916209380 916209400 916209420 916209440 916209460 916211320 916211340 916211360 916211380 916211400 916211420 916211440 916211460 916213320 916213340 916213360 916213380 916213400 916213420 916213440 916213460 925200320 925209320 925209340 925209360 925209380 925209400 925209420 925209440 925209460 925211340 925211360 925211380 925211400 925211420 925211440 925211460 925213320 925213340 925213360 925213380 925213400 925213420 925213440 925213460 926209320 926209340 926209360 926209380 926209400 926209420 926209440 926209460 926211320 926211340 926211360 926211380 926211400 926211420 926211440 926213320 926213340 926213360 926213380 926213400 926213420 926213440 926213460 935209320 935209340 935209360 935209380 935209400 935209420 935209440 935209460 935211320 935211340 935211360 935211380 935211400 935211420 935211440 935211460 935213320 935213340 935213360 935213380 935213400 935213420 935213440 935213460 936213320 936213340 936213360 936213380 936213400 936213420 936213440 936213460 936309320 936309340 936309360 936309380 936309400 936309420 936309440 936309460 936311320 936311340 936311360 936311380 936311400 936311420 936311440 936311460
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    USA (nationwide)
  • 제품 설명
    ACE Trochanteric Nail System || STER L H TROC NAIL 320X9X125 || STER L H TROC NAIL 340X9X125 || STER L H TROC NAIL 360X9X125 || STER L H TROC NAIL 380X9X125 || STER L H TROC NAIL 400X9X125 || STER L H TROC NAIL 420X9X125 || STER L H TROC NAIL 440X9X125 || STER L H TROC NAIL 460X9X125 || STER L H TROC NAIL 320X11X125 || STER L H TROC NAIL 340X11X125 || STER L H TROC NAIL 360X11X125 || STER L H TROC NAIL 380X11X125 || STER L H TROC NAIL 400X11X125 || STER L H TROC NAIL 420X11X125 || STER L H TROC NAIL 440X11X125 || STER L H TROC NAIL 460X11X125 || STER L H TROC NAIL 320X13X125 || STER L H TROC NAIL 340X13X125 || STER L H TROC NAIL 360X13X125 || STER L H TROC NAIL 380X13X125 || STER L H TROC NAIL 400X13X125 || STER L H TROC NAIL 420X13X125 || STER L H TROC NAIL 440X13X125 || STER L H TROC NAIL 460X13X125 || STER R H TROC NAIL 320X9X125 || STER R H TROC NAIL 340X9X125 || STER R H TROC NAIL 360X9X125 || STER R H TROC NAIL 380X9X125 || STER R H TROC NAIL 400X9X125 || STER R H TROC NAIL 420X9X125 || STER R H TROC NAIL 440X9X125 || STER R H TROC NAIL 460X9X125 || STER R H TROC NAIL 320X11X125 || STER R H TROC NAIL 340X11X125 || STER R H TROC NAIL 360X11X125 || STER R H TROC NAIL 380X11X125 || STER R H TROC NAIL 400X11X125 || STER R H TROC NAIL 420X11X125 || STER R H TROC NAIL 440X11X125 || STER R H TROC NAIL 460X11X125 || STER R H TROC NAIL 320X13X125 || STER R H TROC NAIL 340X13X125 || STER R H TROC NAIL 360X13X125 || STER R H TROC NAIL 380X13X125 || STER R H TROC NAIL 400X13X125 || STER R H TROC NAIL 420X13X125 || STER R H TROC NAIL 440X13X125 || STER R H TROC NAIL 460X13X125 || STER L H TROC NAIL 320X11X130 || STER L H TROC NAIL 320X9X130 || STER L H TROC NAIL 340X9X130 || STER L H TROC NAIL 360X9X130 || STER L H TROC NAIL 380X9X130 || STER L H TROC NAIL 400X9X130 || STER L H TROC NAIL 420X9X130 || STER L H TROC NAIL 440X9X130 || STER L H TROC NAIL 460X9X130 || STER L H TROC NAIL 340X11X130 || STER L H TROC NAIL 360X11X130 || STER L H TROC NAIL 380X11X130 || STER L H TROC NAIL 400X11X130 || STER L H TROC NAIL 420X11X130 || STER L H TROC NAIL 440X11X130 || STER L H TROC NAIL 460X11X130 || STER L H TROC NAIL 320X13X130 || STER L H TROC NAIL 340X13X130 || STER L H TROC NAIL 360X13X130 || STER L H TROC NAIL 380X13X130 || STER L H TROC NAIL 400X13X130 || STER L H TROC NAIL 420X13X130 || STER L H TROC NAIL 440X13X130 || STER L H TROC NAIL 460X13X130 || STER R H TROC NAIL 320X9X130 || STER R H TROC NAIL 340X9X130 || STER R H TROC NAIL 360X9X130 || STER R H TROC NAIL 380X9X130 || STER R H TROC NAIL 400X9X130 || STER R H TROC NAIL 420X9X130 || STER R H TROC NAIL 440X9X130 || STER R H TROC NAIL 460X9X130 || STER R H TROC NAIL 320X11X130 || STER R H TROC NAIL 340X11X130 || STER R H TROC NAIL 360X11X130 || STER R H TROC NAIL 380X11X130 || STER R H TROC NAIL 400X11X130 || STER R H TROC NAIL 420X11X130 || STER R H TROC NAIL 440X11X130 || STER R H TROC NAIL 320X13X130 || STER R H TROC NAIL 340X13X130 || STER R H TROC NAIL 360X13X130 || STER R H TROC NAIL 380X13X130 || STER R H TROC NAIL 400X13X130 || STER R H TROC NAIL 420X13X130 || STER R H TROC NAIL 440X13X130 || STER R H TROC NAIL 460X13X130 || STER L H TROC NAIL 320X9X135 || STER L H TROC NAIL 340X9X135 || STER L H TROC NAIL 360X9X135 || STER L H TROC NAIL 380X9X135 || STER L H TROC NAIL 400X9X135 || STER L H TROC NAIL 420X9X135 || STER L H TROC NAIL 440X9X135 || STER L H TROC NAIL 460X9X135 || STER L H TROC NAIL 320X11X135 || STER L H TROC NAIL 340X11X135 || STER L H TROC NAIL 360X11X135 || STER L H TROC NAIL 380X11X135 || STER L H TROC NAIL 400X11X135 || STER L H TROC NAIL 420X11X135 || STER L H TROC NAIL 440X11X135 || STER L H TROC NAIL 460X11X135 || STER L H TROC NAIL 320X13X135 || STER L H TROC NAIL 340X13X135 || STER L H TROC NAIL 360X13X135 || STER L H TROC NAIL 380X13X135 || STER L H TROC NAIL 400X13X135 || STER L H TROC NAIL 420X13X135 || STER L H TROC NAIL 440X13X135 || STER L H TROC NAIL 460X13X135 || STER R H TROC NAIL 320X13X135 || STER R H TROC NAIL 340X13X135 || STER R H TROC NAIL 360X13X135 || STER R H TROC NAIL 380X13X135 || STER R H TROC NAIL 400X13X135 || STER R H TROC NAIL 420X13X135 || STER R H TROC NAIL 440X13X135 || STER R H TROC NAIL 460X13X135 || STER R H TROC NAIL 320X9X135 || STER R H TROC NAIL 340X9X135 || STER R H TROC
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 10 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    903011225 903011230 903011235 903013225 903013230 903013235
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    USA (nationwide)
  • 제품 설명
    ACE Trochanteric Nail System || ACE TROCH NAIL 125 DEG. X 11MM || ACE TROCH NAIL 130 DEG. X 11MM || ACE TROCH NAIL 135 DEG. X 11MM || ACE TROCH NAIL 125 DEG. X 13MM || ACE TROCH NAIL 130 DEG. X 13MM || ACE TROCH NAIL 135 DEG. X 13MM || The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    903208000 903208010 903208015 903208020 903208025
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    USA (nationwide)
  • 제품 설명
    ACE Trochanteric Nail System || STER TROC END CAP || STER TROC END CAP 5MM || STER TROC END CAP 10MM || STER TROC END CAP 15MM || STER TROC END CAP 20MM || STER TROC END CAP 25MM || The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    903209125 903209130 903209135
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    USA (nationwide)
  • 제품 설명
    ACE Trochanteric Nail System || STER TROC NAIL 125 DEG X 9MM || STER TROC NAIL 130 DEG X 9MM || STER TROC NAIL 135 DEG X 9MM || The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    903211070
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    USA (nationwide)
  • 제품 설명
    ACE Trochanteric Nail System || STER TROC LAG SCR 70 MM || The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    903211125 903211130 903211135
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    USA (nationwide)
  • 제품 설명
    ACE Trochanteric Nail System || TROCH NAIL ST 11X180 125DG STRL || TROCH NAIL ST 11X180 130DG STRL || TROCH NAIL ST 11X180 135DG STRL || The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.
  • Manufacturer
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