Devices

Device Recall ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM

  • 모델명 / 제조번호(시리얼번호)
    6021-0740 ACCOLADE PLUS TMZF HIP STEM #7 25138602.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; || V40 taper || Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree neck angle. || Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
  • 1 Event

제조사

Stryker Howmedica Osteonics Corp.
  • 제조사 주소
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA

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Device Recall ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
  • 모델명 / 제조번호(시리얼번호)
    6021-0230 ACCOLADE (127 DEG) SIZE 2 24395205 6021-0230 ACCOLADE (127 DEG) SIZE 2 24955101 6021-0230 ACCOLADE (127 DEG) SIZE 2 25006102 6021-0230 ACCOLADE (127 DEG) SIZE 2 25080402 6021-0230 ACCOLADE (127 DEG) SIZE 2 25108201 6021-0230 ACCOLADE (127 DEG) SIZE 2 25169401 6021-0230 ACCOLADE (127 DEG) SIZE 2 25231102 and 6021-0230 ACCOLADE (127 DEG) SIZE 2 25371202.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; || V40 taper Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree neck angle. || Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
Device Recall ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
  • 모델명 / 제조번호(시리얼번호)
    6021-0335 ACCOLADE (127 DEG) SIZE 3 24295205 6021-0335 ACCOLADE (127 DEG) SIZE 3 24319601 6021-0335 ACCOLADE (127 DEG) SIZE 3 24859104 6021-0335 ACCOLADE (127 DEG) SIZE 3 24991703 6021-0335 ACCOLADE (127 DEG) SIZE 3 25006601 6021-0335 ACCOLADE (127 DEG) SIZE 3 25022201 6021-0335 ACCOLADE (127 DEG) SIZE 3 25045503 6021-0335 ACCOLADE (127 DEG) SIZE 3 25069901 6021-0335 ACCOLADE (127 DEG) SIZE 3 25069902 6021-0335 ACCOLADE (127 DEG) SIZE 3 25069904 6021-0335 ACCOLADE (127 DEG) SIZE 3 25108801 6021-0335 ACCOLADE (127 DEG) SIZE 3 25108802 6021-0335 ACCOLADE (127 DEG) SIZE 3 25169501 6021-0335 ACCOLADE (127 DEG) SIZE 3 25169502 6021-0335 ACCOLADE (127 DEG) SIZE 3 25190102 6021-0335 ACCOLADE (127 DEG) SIZE 3 25211202 6021-0335 ACCOLADE (127 DEG) SIZE 3 25231203 6021-0335 ACCOLADE (127 DEG) SIZE 3 25245201 6021-0335 ACCOLADE (127 DEG) SIZE 3 25245202 6021-0335 ACCOLADE (127 DEG) SIZE 3 25245203 6021-0335 ACCOLADE (127 DEG) SIZE 3 25245204 6021-0335 ACCOLADE (127 DEG) SIZE 3 25255401 6021-0335 ACCOLADE (127 DEG) SIZE 3 25255402 6021-0335 ACCOLADE (127 DEG) SIZE 3 25255403 6021-0335 ACCOLADE (127 DEG) SIZE 3 25255404 6021-0335 ACCOLADE (127 DEG) SIZE 3 25309704 6021-0335 ACCOLADE (127 DEG) SIZE 3 25348701 6021-0335 ACCOLADE (127 DEG) SIZE 3 25400905 6021-0335 ACCOLADE (127 DEG) SIZE 3 25400906 6021-0335 ACCOLADE (127 DEG) SIZE 3 25428401 6021-0335 ACCOLADE (127 DEG) SIZE 3 25428402 6021-0335 ACCOLADE (127 DEG) SIZE 3 25428403 6021-0335 ACCOLADE (127 DEG) SIZE 3 25428404 6021-0335 ACCOLADE (127 DEG) SIZE 3 25459601 and 6021-0335 ACCOLADE (127 DEG) SIZE 3 25467303.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; || V40 taper Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree neck angle. || Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
Device Recall ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
  • 모델명 / 제조번호(시리얼번호)
    6021-0435 ACCOLADE (127 DEG) SIZE 4 24884802 6021-0435 ACCOLADE (127 DEG) SIZE 4 24918803 6021-0435 ACCOLADE (127 DEG) SIZE 4 25045801 6021-0435 ACCOLADE (127 DEG) SIZE 4 25045802 6021-0435 ACCOLADE (127 DEG) SIZE 4 25069801 6021-0435 ACCOLADE (127 DEG) SIZE 4 25080502 6021-0435 ACCOLADE (127 DEG) SIZE 4 25094901 6021-0435 ACCOLADE (127 DEG) SIZE 4 25108901 6021-0435 ACCOLADE (127 DEG) SIZE 4 25138302 6021-0435 ACCOLADE (127 DEG) SIZE 4 25179401 6021-0435 ACCOLADE (127 DEG) SIZE 4 25211501 6021-0435 ACCOLADE (127 DEG) SIZE 4 25231401 6021-0435 ACCOLADE (127 DEG) SIZE 4 25255902 6021-0435 ACCOLADE (127 DEG) SIZE 4 25311401 6021-0435 ACCOLADE (127 DEG) SIZE 4 25311402 6021-0435 ACCOLADE (127 DEG) SIZE 4 25337801 6021-0435 ACCOLADE (127 DEG) SIZE 4 25400803 and 6021-0435 ACCOLADE (127 DEG) SIZE 4 25515602.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; || V40 taper Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree neck angle. || Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
Device Recall ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
  • 모델명 / 제조번호(시리얼번호)
    6021-0537 ACCOLADE (127 DEG) SIZE 5 24992703 6021-0537 ACCOLADE (127 DEG) SIZE 5 24992704 6021-0537 ACCOLADE (127 DEG) SIZE 5 25007601 6021-0537 ACCOLADE (127 DEG) SIZE 5 25080702 6021-0537 ACCOLADE (127 DEG) SIZE 5 25138501 6021-0537 ACCOLADE (127 DEG) SIZE 5 25138503 6021-0537 ACCOLADE (127 DEG) SIZE 5 25231501 and 6021-0537 ACCOLADE (127 DEG) SIZE 5 25296301.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; || V40 taper || Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree neck angle. || Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
Device Recall ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
  • 모델명 / 제조번호(시리얼번호)
    6021-0637 ACCOLADE (127 DEG) SIZE 6 24955501 6021-0637 ACCOLADE (127 DEG) SIZE 6 25109001 and 6021-0637 ACCOLADE (127 DEG) SIZE 6 25337903.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Accolade TMZF Plus Hip Stem; Hydroxylapatite coated, Titanium Plasma Spray; || V40 taper || Longitudinal Grooves, Stem Length 120mm, Head Offset - 43mm, 127 degree neck angle. || Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
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