Device Recall Zimmer

  • Modelo / Serial
    lot no.: 62012579 62086025 62086025N 62055993 62264285 62362923 62264285N 62151833 62284483 62362921 62284483N 62224932 62284484 62340084 61886896 62043474 62141793 62284485 62362930 62284485N 62240754 62293494
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Product 57 consists of all product code: JDI and same usage: || Item no: || 763401000 PRESSFIT FEM ST FX 10 X 115 || 763401100 PRESSFIT FEM ST FX 11 X 1 || 763401200 PRESSFIT FEM ST FX 12 X 1 || 763401300 PRESSFIT FEM ST FX 13 X 1 || 763401400 PRESSFIT FEM ST FX 14 X 1 || 763401500 PRESSFIT FEM ST FX 15 X 1 || For use in total or hemi hip arthroplasty
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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

263 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Part 47-2492-320-10; lot 62763724
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution. US states of NC and AK; Taiwan, Japan, and Germany.
  • Descripción del producto
    ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
  • Manufacturer
  • Modelo / Serial
    00-2228-024-00 2.4MM Diameter Bullet Tip Guide Wire; 00-2255-025-00 Humeral Smooth Guide Wire 2.4mm 70cm Length; 00-2255-026-00 Humeral Bullet Tip Guide Wire 2.4mm Diameter 70cm Length; 47-2237-033-00 Smooth Guide Wire 2.4mm Diameter 100cm Length; 47-2237-037-00 3.0MM Diameter Smooth Guide Wire 100cm Length; 47-2237-038-00 Bullet Tip Guide Wire 3.0mm Diameter 100cm Length; 47-2255-008-00 Ball Tip Guide Wire 2.4mm Diameter 70cm Length; 47-2255-008-01 Ball Tip Guide Wire 3.0mm Diameter 100cm Length All non-expired, distributed lots with a 10 year expiration date on the label.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) including Puerto Rico and Virgin Islands., and to the countries of Canada, Brazil, Algeria, Mexico, Austria, Taiwan, Belgium, Hong Kong, Croatia, Singapore, Denmark, Bahamas, Egypt, Panama, Finland, Dominican Republic, France, Guatemala, Germany, Australia, Ireland, Japan,Italy, Haiti, Jordan, Malaysia, Kenya, India, Lebanon, Luxembourg, Malta, Mauritius, Morocco, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, United Kingdom and United Arab Emirates.
  • Descripción del producto
    Zimmer Guide Wires for orthopedic procedures.
  • Manufacturer
  • Modelo / Serial
    Model # 01-8507-400-00 & Model # 89-8507-400-00
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : AR, CA, CO, CT, FL, GA, HI, IL, KS, KY, LA, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, PA, RI, SC, TX, UT, VA, WA, WI, WV and WY.
  • Descripción del producto
    Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. Rx only Made in Switzerland
  • Manufacturer
  • Modelo / Serial
    lot #62460264
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution and the country of Thailand.
  • Descripción del producto
    Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; || Lot Number:62460264. || Indicated for patients with severe knee pain and disability and is intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum alloy femoral component to perform knee arthroplasty.
  • Manufacturer
  • Modelo / Serial
    Synvasive Part number: 11-4770; Part number: 19075127YT1;  Lot numbers: 45104 and 43054.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to one location each in CT, MA and CA.
  • Descripción del producto
    Zimmer Oscillating Flat - TS ST Hub; || 75mm x 19mm x 1.00/1.27mm; || Synvasive Part No. 11-4770: || Part No. 19075127YT1; || Lot No. 45104 and 43054 || Description: STRYK_76542K_19X75X1.27T || General and Plastic Surgery: The oscillating surgical saw blade is intended for use with powered equipment to resect bone and/or cartilage in orthopedic procedures
  • Manufacturer
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