Zimmer Trilogy

  • Model / Serial
    REF 6200-056-22, lot 62010615
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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

9 devices with a similar name

Learn more about the data here

  • Model / Serial
    Model: 80 models, Affected: Manufactured since March 2009
  • Manufacturer
  • Model / Serial
    Model: Item Numbers: 00-6250-065-35 & 00-6250-065-25, Affected: Lot Numbers: 62748089, 62793494, 62793501, 62813612 & 62825611
  • Manufacturer
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Non-active implants - bone surgery
  • Manufacturer
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Implant - orthopedics
  • Manufacturer
4 more