Device Recall LEGION(TM) HK FEMORAL ASSEMBLY

  • Modèle / numéro de série
    Lot codes: 15KM09184,15LM08835,15LM08837,15LM08839,15LM08840
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    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.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • Société-mère du fabricant (2017)
  • Source
    USFDA

5 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Lot codes: 15LM08792,15LM15638,15LM15639,15MM03011,15MM03012,15MM03014,15MM09814
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    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.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Lot Code: 15LM08798
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    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.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Lot codes: 15KM09161,15KM09163,15KM09175,15KM17714,15KM17800,15KM17806,15KM17809,15KM17817,15LM01258,15LM01259,15LM01260,15LM01261,15LM08803,15LM08816,15LM08820,15LM08821,71421375,15KM09183
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    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.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Lot codes: 15KM20807,15KM20808,15KM20811,15KM20812,15LM08258,15LM12482,15MM03005,15MM03007
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    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.
  • Description du dispositif
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    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.
  • Description du dispositif
    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