Device Recall DEPUY ASR ACETABULAR CUP SYSTEM

  • Modelo / Serial
    Part Number 999890251, Size 51, All lots.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide
  • Descripción del producto
    ASR UNI FEMORAL IMPL SIZE 51, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy ASR (Articular Surface Replacement) Hip System. || The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral bead, and a taper sleeve adapter. || The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. || The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. || The taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima¿ Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12. || Prescription Use, Sterile. || The DePuy ASR Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Depuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Source
    USFDA

32 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Part Number 999890340, ASR Taper Sleeve Adapter Size 11/13+0, All lots.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide
  • Descripción del producto
    ASR TAP SLV ADAP 11/13 +0, DEPUY ASR ACETABULAR CUP SYSTEM-PRIMARY or ULTIMA* UNIPOLAR HEAD AND ADAPTER SLEEVES -SECONDARY. || The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. || The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. || Prescription Use, Sterile || The DePuy ASR Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
  • Manufacturer
  • Modelo / Serial
    Part Number 999890343, ASR Taper Sleeve Adapter Size 11/13+3, All lots.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide
  • Descripción del producto
    ASR TAP SLV ADAP 11/13 +3, DEPUY ASR ACETABULAR CUP SYSTEM-PRIMARY and ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES -SECONDARY. || The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. || The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. || Prescription Use, Sterile. || The DePuy ASR Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
  • Manufacturer
  • Modelo / Serial
    Part Number 999890346, ASR Taper Sleeve Adapter Size 11/13+6, All lots.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide
  • Descripción del producto
    ASR TAP SLV ADAP 11/13 +6, DEPUY ASR ACETABULAR CUP SYSTEM-PRIMARY and ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES -SECONDARY. || The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. || The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. || Prescription Use, Sterile. || The DePuy ASR Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
  • Manufacturer
  • Modelo / Serial
    Part Number 999890349, ASR Taper Sleeve Adapter Size 11/13+9, All lots
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide
  • Descripción del producto
    ASR TAP SLV ADAP 11/13 +9, DEPUY ASR ACETABULAR CUP SYSTEM-PRIMARY and ULTIMA UNIPOLAR HEAD AND ADAPTER SLEEVES -SECONDARY. || The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. || The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. || Prescription Use, Sterile. || The DePuy ASR Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
  • Manufacturer
  • Modelo / Serial
    Part Number 999800312, ASR Taper Sleeve Adapter Size 12/14+2, All lots.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide
  • Descripción del producto
    ASR TAP SLV ADAP 12/14 +2, DEPUY ASR ACETABULAR CUP SYSTEM, ASR MODULAR ACETABULAR CUP SYSTEM (TRADITIONAL) (A.K.A. ASR XL). || The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. || The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. || Prescription Use, Sterile. || The DePuy ASR Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
  • Manufacturer
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