Device Recall Endotec, Prosthesis Hip

  • 모델명 / 제조번호(시리얼번호)
    Lot No: 01023254CNN379 01023256CNN379 01030036ENN351 01030036ENN363 01030038ENN363 01030038ENN351 01030039G1NN363 01030039G1NN351 01030041FNN363 01030041FNN351 01030042ENN351 01030042ENN363 01030044CNN351 01030044CNN363 01030045HNN363 01030045HNN351 01030047G2NN363 01030047HNN351 01030049H2NN363 01030049H2NN351 01030051F1NN363 01030051F1NN351 01030052F1NN363 01030052F1NN351 01040110SNN330 01040111JNN353 01040111QNN330 01040112XNN330 01040112YNN353 01040112YNN326
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution -- US in OH, TX, CA, FL, NJ, TN; and International Distribution: Korea, Australia, Switzerland, The Netherlands, Spain. Domestic: OH, TX, CA, FL, NJ, TN.
  • 제품 설명
    Endotec Prothesis Hip, Titanium Alloy, Sterilized. || Acetabular Bearing, BP Hip System Component: || 32x54 Acetabular Bearing, Catalog: 01-02-3254, || 32x56 Acetabular Bearing, Catalog: 01-02-3256, || Femoral Head Resurfacing Component, BP Hip System Component: || 36.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0036, || 38mm Femoral Head Resurfacing Component:, Catalog: 01-03-0038, || 39.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0039, || 41mm Femoral Head Resurfacing Component:, Catalog: 01-03-0041, || 42.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0042, || 44mm Femoral Head Resurfacing Component:, Catalog: 01-03-0044, || 45.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0045, || 47mm Femoral Head Resurfacing Component:, Catalog: 01-03-0047, || 49mm Femoral Head Resurfacing Component:, Catalog: 01-03-0049, || 51mm Femoral Head Resurfacing Component:, Catalog: 01-03-0051, || 52mm Femoral Head Resurfacing Component:, Catalog: 01-03-0052. || Femoral Stem BP Hip System Component: || 10mm Femoral Stem Catalog: 01-04-0110, || 11mm Femoral Stem Catalog: 01-04-0111, || 12mm Femoral Stem Catalog: 01-04-0112.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Endotec, Inc., 2546 Hansrob Rd, Orlando FL 32804-3318
  • 제조사 모회사 (2017)
  • Source
    USFDA