Device Recall Persona, The Personalized Knee System

  • Modèle / numéro de série
    Part Number 42-5399-022-05, Lot 62032102, 62087056
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
  • Description du dispositif
    Persona, The Personalized Knee System, Tibial Broach, Cemented, Size E-F, Nonsterile, || This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA

10 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Part Number 42-5399-018-00,Lot 77001868
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
  • Description du dispositif
    Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diameter, Nonsterile || This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities.
  • Manufacturer
  • Modèle / numéro de série
    Part Number 42-5399-020-00, Lot 62059525, 62087055
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
  • Description du dispositif
    Persona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 mm Diameter, Nonsterile, Nonsterile || This drill guide is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities
  • Manufacturer
  • Modèle / numéro de série
    Part Number 42-5399-022-03, Lot 62032101, 62117750
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
  • Description du dispositif
    Persona, The Personalized Knee System, Tibial Broach,, Cemented, Size C-D, Nonsterile, || This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities.
  • Manufacturer
  • Modèle / numéro de série
    Part Number 42-5399-022-07, Lot 62032102, 62087056, 62162437
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
  • Description du dispositif
    Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Nonsterile, || This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities.
  • Manufacturer
  • Modèle / numéro de série
    Part Number 42-5399-064-01(left) Lot 62052717, 62079727, 62121519 Part 42-5399-064-02 (right) Lot 62055081, 62121526   Part Number 42-5399-064-02 (right)
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
  • Description du dispositif
    Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size C Left; Size C Right || This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities
  • Manufacturer
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