Persona

  • Modèle / numéro de série
    Lot Numbers:  62155015 62165014 62165015 62165016 62165017 62165018 62182742 62182743 62188282 62188283 62191355 62191361 62191366 62191372 62210290 62210291 62227943 62230668 62230669 62230670 62230671 62230672 62230673 62230674 62230675 62230676 62255591 62255592 62255593 62255594 62255595 62255596 62255597 62255598 62283576 62283577 62283578 62288220 62288221 62288222 62288223 62288224 62305911 62305912 62305913 62305914 62327983 62327985 62327987 62327988 62327989 62348078 62348079 62348080 62348091 62348092 62348095 62379888 62379889 62379890 62379891 62391801 62391802 62391803 62391804 62391805 62391807 62391808 62408432 62408438 62408439 62408440 62408441 62417035 62417036 62417037 62444920 62444921 62444922 62444925 62453583 62453584 62453585 62475432 62475433 62475434 62475435
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the states of : HI, CA, UT, NY, OH, IN, AL, FL, GA, WI, IA, MN, NE, SD, NJ, PA, ND, IL, MO, VA, MD, NC, MI, OR, WA, KS, KY, TN, WV, OK, CT, MA, ME, AZ, NM, TX, LA, ID, CO, MT, UT, NV and AK., and Internationally to Singapore, Japan, Germany and Canada.
  • Description du dispositif
    Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation, single use.
  • 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

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    Model: Selected part numbers (48 items), Affected: All lots
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176 en plus