Devices

Device Recall Persona The Personalized Knee System, Natural Tibia

  • Modèle / numéro de série
    Part Number 42-5320-083-01 TIBIA SIZE H, LEFT, Lot: 11006513, 11006722, 11007119, 62018828, 62018829, 62033403, 62060748, 62068423, 62076595, 62079771, 62091371, 62110207, 62117667 Part Number 42-5320-083-02 TIBIA SIZE H, RIGHT, Lot: 11007062, 11007123, 62018830, 62018831, 62033404, 62051804, 62060749, 62068424, 62076597, 62079772, 62091372, 62117668, 77001707
  • Classification du dispositif
    Orthopedic Devices
  • 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, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile || TIBIA SIZE H, LEFT || TIBIA SIZE H RIGHT || 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
    Zimmer, Inc.
  • 1 Event

Fabricant

Zimmer, Inc.
  • Adresse du fabricant
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • 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