Device Recall Zimmer

  • Modelo / Serial
    lot no.: 62127759 62196525 61955423 62289877 62052696 62052696N 62144719 61930078 62138079 62052697 61960862 62253596 62253596N 62027415 62052698 62052699 61567438 61966260 61966261 61966262 61966263 61966264 61966265 61641810 61903337 61903338 61898112 62138080 61903334 61903335 61903336 61966254
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Product 56 consists of all product under product code: HWC and same usage: || Item no: || 47234702032 PERI SCR 3.5MM X 32MM STE || 47234702018 PERI SCR. 3.5MM X 18MM ST || 47234702020 PERI SCR. 3.5MM X 20MM ST || 47234702022 PERI SCR. 3.5MM X 22MM ST || 47234702026 PERI SCR. 3.5MM X 26MM ST || 47234702030 PERI SCR. 3.5MM X 30MM ST || 47234702034 PERI SCR. 3.5MM X 34MM ST || 47234702036 PERI SCR. 3.5MM X 36MM ST || 47234702042 PERI SCR. 3.5MM X 42MM ST || 47234702046 PERI SCR. 3.5MM X 46MM ST || 47234702050 PERI SCR. 3.5MM X 50MM ST || 47234702080 PERI SCR. 3.5MM X 80MM ST || 47234702085 PERI SCR. 3.5MM X 85MM ST || 47234702155 PERI SCR. 4.0MM X 55MM || 47234702160 PERI SCR. 4.0MM X 60MM || 47234702210 PERI SCR. 4.0MMX10MM FULL || 47234702212 PERI SCR. 4.0MMX12MM FULL || 47234702214 PERI SCR. 4.0MMX14MM FULL || 47234702216 PERI SCR. 4.0MMX16MM FULL || 47234702260 PERI SCR. 4.0MMX60MM FULL || 47234702336 PERI SCR. 4.5MM X 36MM || 47234702338 PERI SCR. 4.5MM X 38MM || 47234712440 PERI SCR. 6.5MM X 140MM || 47234702670 PERI SCR. 6.5MM X 70MM || 47234702122 PERI. SCR 4.0MM X22MM || 47234702124 PERI. SCR 4.0MM X24MM || 47234702126 PERI. SCR 4.0MM X26MM || 47234702128 PERI. SCR 4.0MM X28MM || 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 2385941.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Maryland.
  • Descripción del producto
    Zimmer Anatomical Shoulder Prosthesis, Glenoid, Cemented, sterile; REF 01.04214.370.
  • Manufacturer
  • Modelo / Serial
    Lot No: 60646894.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide: USA including states of Arizona, California, Florida, Georgia, Indiana, Michigan, New York, North Carolina, and Virginia, and countries of Germany and Japan.
  • Descripción del producto
    Zimmer Minimally Invasive Solutions Technology, Offset Rasp Handle, Left, 45 degrees, non-sterile; REF/Catalog #: 7712-35-01, Zimmer U.K. Ltd., SN3, 4FP, UK
  • Manufacturer
  • Modelo / Serial
    Lot No: 60651168 and 60726506.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide: USA including states of Arizona, California, Florida, Georgia, Indiana, Michigan, New York, North Carolina, and Virginia, and countries of Germany and Japan.
  • Descripción del producto
    Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; REF 7712-35-02, Zimmer U.K. Ltd., SN3, 4FP, UK
  • Manufacturer
  • Modelo / Serial
    Lot Numbers: 60009294, 60075254, 60101562, 60156041, 60215686, 60271994, 60314032, 60389073, 60440024, 60506573 and 60590575.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide-USA, Australia, Canada, Colombia, Denmark, Dubai, Italy, Japan, Mexico and Singapore.
  • Descripción del producto
    Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF: 00-2550-001-10, 400 ml INF. Cntrl. Kit w/ 3/32" drain, 2.4 mm, 7Fr, PVC, 107 cm, small, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio.
  • Manufacturer
  • Modelo / Serial
    All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.
  • Descripción del producto
    Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/8" Drain , 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-020-05.
  • Manufacturer
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