Device Recall LEGION(TM) HK FEMORAL ASSEMBLY

  • 모델명 / 제조번호(시리얼번호)
    Lot codes: 15KM09184,15LM08835,15LM08837,15LM08839,15LM08840
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.
  • 제품 설명
    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 || The LEGION Hinge Knee System is indicated for: || 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. || The LEGION Hinge Knee System is for cemented use only.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 5 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot codes: 15LM08792,15LM15638,15LM15639,15MM03011,15MM03012,15MM03014,15MM09814
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.
  • 제품 설명
    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 || The LEGION Hinge Knee System is indicated for: || 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. || The LEGION Hinge Knee System is for cemented use only.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Code: 15LM08798
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.
  • 제품 설명
    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363 || The LEGION Hinge Knee System is indicated for: || 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. || The LEGION Hinge Knee System is for cemented use only.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot codes: 15KM09161,15KM09163,15KM09175,15KM17714,15KM17800,15KM17806,15KM17809,15KM17817,15LM01258,15LM01259,15LM01260,15LM01261,15LM08803,15LM08816,15LM08820,15LM08821,71421375,15KM09183
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.
  • 제품 설명
    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 71421374 || The LEGION Hinge Knee System is indicated for: || 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. || The LEGION Hinge Knee System is for cemented use only.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot codes: 15KM20807,15KM20808,15KM20811,15KM20812,15LM08258,15LM12482,15MM03005,15MM03007
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.
  • 제품 설명
    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364 || The LEGION Hinge Knee System is indicated for: || 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. || The LEGION Hinge Knee System is for cemented use only.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot codes: 15JM04561,15JM04570,15JM04589,15KM08936,15KM08937,15KM08940,15KM08942,15KM08948,15KM08949,15KM09010,15KM09011,15KM09013,15KM09014,15KM09015,15KM09016,15LM09119,15LM09122,15LM09123,15LM09124,15LM12483,15LM12484,15LM12486,15LM12488,15LM15652,15MM09829,15MM09833,16AM12222,16AM12224,16AM12235,16AM12237,16AM12240,16AM12243,16AM12255,16AM12268
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.
  • 제품 설명
    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365 || The LEGION Hinge Knee System is indicated for: || 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. || The LEGION Hinge Knee System is for cemented use only.
  • Manufacturer