Zimmer Trilogy

  • Modèle / numéro de série
    REF 6200-056-22, lot 62010615
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution--USA (nationwide) including the states of AL, CA, CT, KS, MA, MD, MN, MO, NY, SD, TX and WI and the countries of Bulgaria,Canada, Germany, Italy, Netherlands, Russian Fed, Sweden and UK
  • Description du dispositif
    The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile || The Trilogy Acetabular System is indicated for either cemented or uncemented use In skeletally mature Individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused Hip, fracture of the pelvis, and diastrophic variant. The shells with screw holes permit the use of titanium alloy screws to provide additional fixation and security, particularly in those cases where acetabular bone stock is deficient.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 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: 80 models, Affected: Manufactured since March 2009
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    Model: Item Numbers: 00-6250-065-35 & 00-6250-065-25, Affected: Lot Numbers: 62748089, 62793494, 62793501, 62813612 & 62825611
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  • Dispositif implanté ?
    Yes
  • Description du dispositif
    Non-active implants - bone surgery
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  • Modèle / numéro de série
  • Dispositif implanté ?
    Yes
  • Description du dispositif
    Implant - orthopedics
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