Device Recall Persona Cemented Tibial Broach Inserter/Extractor

  • Modèle / numéro de série
    Item: 42-5399-023-00 Lots: 62072307 62072565 62085420 62192754
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in the states of MN; NJ; NC; PA; AL; MI; OR; FL; OH; CO; IL and CA, and the countries of Australia, India, UAE, Germany, and Italy.
  • Description du dispositif
    Persona Cemented Tibial Broach Inserter/Extractor. || The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA procedures. The Persona Surgical Technique indicates that the Persona Cemented Tibial Broach Inserter/Extractor Handle is intended to broach the proximal tibia in preparation for the full seating of the tibial implant.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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