Device Recall Regenerex Patella

  • 모델명 / 제조번호(시리얼번호)
    All lots of Model #'s:  141355 141356 141357 141358
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide.distribution and Canada.
  • 제품 설명
    Regenerex Patella || RGX 3 PEG SER A PATELLA 28MM || RGX 3 PEG SER A PATELLA 31MM || RGX 3 PEG SER A PATELLA 34MM || RGX 3 PEG SER A PATELLA 37MM || Product Usage: || The Regenerex Series A Patella can be used for any non-cemented resurfaced 3-peg patella application within the Vanguard Complete Knee System. 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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