Device Recall Zyston Transform TLIF System

  • Modèle / numéro de série
    Lot Numbers: 2016234237; 2016234240; 2016234242; 2016234243; 2016234245; 2016234246; 2016234247; 2016234248; 2016234249; 2016234351.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.
  • Description du dispositif
    Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer Biomet Spine, Inc, 310 Interlocken Pkwy, Suite 120, Broomfield CO 80021-3479
  • 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

Un dispositif médical avec un nom similaire

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  • Modèle / numéro de série
    Lot Numbers: 2016244391; 2016244394; 2016244395; 2016244396; 2016244397; 2016244424; 2016244426; 2016244427; 2016244428; 2016244430.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.
  • Description du dispositif
    Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
  • Manufacturer