Device Recall DEPUY ASR 300 ACETABULAR CUP SYSTEM

  • 모델명 / 제조번호(시리얼번호)
    Part Number 999830746, Size 46, All lots.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide
  • 제품 설명
    ASR 300 Size 46, DEPUY ASR 300 ACETABULAR CUP SYSTEM. || The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. || Prescription Use, Sterile || The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. The device 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. Porous-coated ASR 300 Acetabular Cups are indicated for cementless application. The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR 300 Acetabular Cup System is compatible with ASR femoral components.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Depuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Source
    USFDA

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  • 모델명 / 제조번호(시리얼번호)
    Part Number 999830744, Size 44, All lots.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide
  • 제품 설명
    ASR 300 Size 44, DEPUY ASR 300 ACETABULAR CUP SYSTEM. || The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. || Prescription Use, Sterile || The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. The device 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. Porous-coated ASR 300 Acetabular Cups are indicated for cementless application. The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR 300 Acetabular Cup System is compatible with ASR femoral
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Part Number 999830748, Size 48, All lots.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide
  • 제품 설명
    ASR 300 Size 48, DEPUY ASR 300 ACETABULAR CUP SYSTEM. || The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. || Prescription Use, Sterile || The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. The device 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. Porous-coated ASR 300 Acetabular Cups are indicated for cementless application. The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR 300 Acetabular Cup System is compatible with ASR femoral components.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Part Number 999830750, Size 50, All lots.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide
  • 제품 설명
    ASR 300 Size 50, DEPUY ASR 300 ACETABULAR CUP SYSTEM. || The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. || Prescription Use, Sterile || The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. The device 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. Porous-coated ASR 300 Acetabular Cups are indicated for cementless application. The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR 300 Acetabular Cup System is compatible with ASR femoral
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Part Number 999830752, Size 52, All lots.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide
  • 제품 설명
    ASR 300 Size 52, DEPUY ASR 300 ACETABULAR CUP SYSTEM. || The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. || Prescription Use, Sterile. || The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. The device 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. Porous-coated ASR 300 Acetabular Cups are indicated for cementless application. The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR 300 Acetabular Cup System is compatible with ASR femoral
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Part Number 999830754, Size 54, All lots.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide
  • 제품 설명
    ASR 300 Size 54, DEPUY ASR 300 ACETABULAR CUP SYSTEM. || The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. || Prescription Use, Sterile || The DePuy ASR 300 Acetabular Cup System is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. The cups feature three spikes for adjunct fixation and are available in ten sizes. The device 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. Porous-coated ASR 300 Acetabular Cups are indicated for cementless application. The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR 300 Acetabular Cup System is compatible with ASR femoral
  • Manufacturer
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