Device Recall Zimmer

  • Modelo / Serial
    lot no.: 62050736 62230456 62261576 61976745 62127763 62230457 62261627 62261659 61955473
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Product 18 consists of all product under product code: HWC and same usage: || Item no: || 47248001441 CANC SCR 4.0MM X 14MM FUL || 47248001641 CANC SCR 4.0MM X 16MM FUL || 47248001840 CANC SCR 4.0MM X 18MM || 47248001841 CANC SCR 4.0MM X 18MM FUL || 47248002041 CANC SCR 4.0MM X 20MM FUL || 47248002441 CANC SCR 4.0MM X 24MM FUL || 47248003641 CANC SCR 4.0MM X 36MM FUL || Product Usage: || A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
  • 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
    Lot 2299218.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Florida, Pennsylvania, Texas and Virginia.
  • Descripción del producto
    Zimmer Metasul Head 32/-4'S', taper 12/14, hip implant component; REF 19.32.05.
  • Manufacturer
  • Modelo / Serial
    Lot 60954069.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Florida, China and India.
  • Descripción del producto
    Zimmer M/G Unicompartmental Knee System headed screw, 48 mm length, sterile, Catalog No. 00-5791-041-00. Used during surgery for the cutting guide. This screw is not permanently implanted.
  • Manufacturer
  • Modelo / Serial
    All units.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide, Australia, China, England, France, Germany, India, Italy, Japan, Korea, Singapore and Taiwan.
  • Descripción del producto
    Zimmer NEXGEN Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor (a pounding instrument used during knee surgery), nonsterile, Zimmer, Warsaw, Indiana; REF 5951-90..
  • Manufacturer
  • Modelo / Serial
    All lots.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution --- including USA and countries of Austria, Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Dubai, England, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Korea, Lebanon, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Slovakia, Spain, Switzerland and Ukraine.
  • Descripción del producto
    Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length +3.5 mm, sterile, Zimmer, Warsaw, IN; REF 00-6418-032-03 and 00-6428-032-03. || The Alumina Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.
  • Manufacturer
  • Modelo / Serial
    Lots P050120 and P041466.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- USA including states of California, Minnesota, Ohio, Pennsylvania, and Tennessee, and countries of Denmark, Germany, Iran, Italy, Russia, Singapore, Spain, Switzerland, and United Kingdom.
  • Descripción del producto
    Zimmer Silhouette Axial Torque Handle, Zimmer Spine, Inc., Minneapolis, MN; REF 7010-0151-01. || Reusable instrument that is used to apply the appropriate torque to the lock nut that is part of the Silhouette Spinal Fixation System.
  • Manufacturer
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