Devices

Device Recall ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM

  • 모델명 / 제조번호(시리얼번호)
    6020-4535 ACCOLADE 132 SIZE 4.5 24884902 6020-4535 ACCOLADE 132 SIZE 4.5 24955901 6020-4535 ACCOLADE 132 SIZE 4.5 25008201 6020-4535 ACCOLADE 132 SIZE 4.5 25095501 6020-4535 ACCOLADE 132 SIZE 4.5 25387501 6020-4535 ACCOLADE 132 SIZE 4.5 25387502 and 6020-4535 ACCOLADE 132 SIZE 4.5 25387504.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper, Sterile. 132 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 HA 132 DEGREE SIZE 0 HIP STEM
  • 모델명 / 제조번호(시리얼번호)
    Item Number Description Lot Number 6020-0130 ACCOLADE 132 SIZE 1 25107601 6020-0130 ACCOLADE 132 SIZE 1 25370101 and 6020-0130 ACCOLADE 132 SIZE 1 25370103.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper, Sterile. 132 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 HA 132 DEGREE SIZE 0 HIP STEM
  • 모델명 / 제조번호(시리얼번호)
    6020-0230 ACCOLADE 132 SIZE 2 24990805 6020-0230 ACCOLADE 132 SIZE 2 25079801 6020-0230 ACCOLADE 132 SIZE 2 25107701 6020-0230 ACCOLADE 132 SIZE 2 25187502 6020-0230 ACCOLADE 132 SIZE 2 25187503 6020-0230 ACCOLADE 132 SIZE 2 25187505 and 6020-0230 ACCOLADE 132 SIZE 2 25335502.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper, Sterile. 132 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 HA 132 DEGREE SIZE 0 HIP STEM
  • 모델명 / 제조번호(시리얼번호)
    6020-0335 ACCOLADE 132 SIZE 3 24972401 6020-0335 ACCOLADE 132 SIZE 3 25004402 6020-0335 ACCOLADE 132 SIZE 3 25045302 6020-0335 ACCOLADE 132 SIZE 3 25045303 6020-0335 ACCOLADE 132 SIZE 3 25107804 6020-0335 ACCOLADE 132 SIZE 3 25178601 6020-0335 ACCOLADE 132 SIZE 3 25230801 6020-0335 ACCOLADE 132 SIZE 3 25230802 6020-0335 ACCOLADE 132 SIZE 3 25245502 6020-0335 ACCOLADE 132 SIZE 3 25245503 6020-0335 ACCOLADE 132 SIZE 3 25255101 6020-0335 ACCOLADE 132 SIZE 3 25274002 6020-0335 ACCOLADE 132 SIZE 3 25348901 and 6020-0335 ACCOLADE 132 SIZE 3 25386101.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper, Sterile. 132 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 HA 132 DEGREE SIZE 0 HIP STEM
  • 모델명 / 제조번호(시리얼번호)
    6020-0537 ACCOLADE 132 SIZE 5 25189704 and 6020-0537 ACCOLADE 132 SIZE 5 25189705.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper, Sterile. 132 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 HA 132 DEGREE SIZE 0 HIP STEM
  • 모델명 / 제조번호(시리얼번호)
    6020-0637 ACCOLADE 132 SIZE 6 25080301 and 6020-0637 ACCOLADE 132 SIZE 6 25189901.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper, Sterile. 132 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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