Device Recall Persona The Personalized Knee System

  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
  • 제품 설명
    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
  • 1 Event

제조사

  • 제조사 주소
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 제조사 모회사 (2017)
  • 제조사 의견
    “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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 6 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Item# 42-5320-067-02 Lot # 63236047
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Non-USA Customer
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    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,
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    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,
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
  • 제품 설명
    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
하나 더 1 건 더