Device Recall Persona The Personalized Knee System

  • Modelo / Serial
    Part Number 42-5320-075-01 TIBIA SIZE F, LEFT, Lot: 11006654, 11007213, 11007237, 62018347, 62018348, 62033393, 62040514, 62060745, 62068420, 62076584, 62079762, 62079763, 62079764, 62091367, 62110202, 62110203, 62117661, 62144988,  Part Number 42-5320-075-02 TIBIA SIZE F RIGHT, Lot: 11006575, 11006983, 11007033, 62018349, 62018350, 62033395, 62040515, 62065655, 62067342, 62076587, 62079765, 62079766, 62091368, 62110204, 62117662, 62103728, 11007768, 62140221, 62144989,
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
  • Descripción del producto
    Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile || TIBIA SIZE F, LEFT || TIBIA SIZE F 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
  • 1 Event

Fabricante

  • Dirección del fabricante
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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

6 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Item# 42-5320-067-02 Lot # 63236047
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Non-USA Customer
  • Descripción del producto
    PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
  • Manufacturer
  • Modelo / Serial
    Part Number 42-5320-064-01 TIBIA SIZE C, LEFT Lots: 62018336, 62018337, 62033380, 62051020, 62060739, 62068413, 62076438, 62079740, 62091360, 62117665, and 77001708,  Part Number 42-5320-064-02 TIBIA SIZE C RIGHT Lot: 62018338, 62018339, 62033383, 62051021, 62060740, 62060742, 62068415, 62076439, 62079741, 62091361,and 62117666
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
  • Descripción del producto
    Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile || SIZE C, LEFT; SIZE C 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
  • Modelo / Serial
    Part Number 42-5320-067-01 TIBIA SIZE D, LEFT, Lot: 62018341, 62018342, 62030572, 62030573, 62033385, 62051022, 62068416, 62076576, 62079742, 62091362, 62103717, 62103718, 62110194, 62117656, 11007593, 11007636, 11007592, 11007635, 11007594, 11007634 Part Number 42-5320-067-02 TIBIA SIZE D RIGHT, Lot: 11006514, 11007138, 11007214, 62018343, 62018344, 62033386, 62040513, 62060743, 62068417, 62076577, 62079743, 62079744, 62091363, 62103720, 62117657, 11007589, 11007590, 11007591, 11007637, 11007638, 11007639, 62140222
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
  • Descripción del producto
    Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile || 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
  • Modelo / Serial
    Part Number 42-5320-071-01 TIBIA SIZE E, LEFT, Lot 11005332, 11005333, 11005334, 11005359, 11005360, 11005361, 11006133, 11006134, 11006135, 11006136, 11006137, 11006138, 11006712, 11007124, 61956760, 61956761, 61956762, 61978561, 61978562, 61978563, 62022179, 62030574, 62033389, 62079745, 62030575, 11007596, 62091364, 62103722, 62060744, 62068418, 62079746, 62103723, 62110198, 62117658, 62076580, 62128899, 11007595, 11007597, 62144992, 62150529, 62150530 ,  Part Number 42-5320-071-02 TIBIA SIZE E RIGHT, Lot 11006515, 11007238, 11007574, 11007575, 11007576, 62018345, 62018346, 62022180, 62022181, 62033391, 62051023, 62051801, 62068419, 62076582, 62079747, 62079761, 62103725, 62110199, 62117659, 62128904, 11007641, 11007640, 11007642,
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
  • Descripción del producto
    Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile || TIBIA SIZE E, LEFT || TIBIA SIZE E 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
  • Modelo / Serial
    Part Number 42-5320-079-01 TIBIA SIZEG, LEFT, Lot 11007106, 62018351, 62018352, 62033397, 62051024, 62060746, 62068421, 62076590, 62079768, 62079769, 62091369, 62117663, 11007728, 62144994 Part Number 42-5320-079-02 TIBIA SIZEG, RIGHT, Lot: 11007168, 11007488, 62018353, 62018354, 62033399, 62051025, 62060747, 62068422, 62076592, 62079770, 62091370, 62103729, 62110206, 62117664, 77001682, 11007727
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
  • Descripción del producto
    Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile || TIBIA SIZE G, LEFT || TIBIA SIZE G 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
Uno más