Device Recall Zimmer

  • Modelo / Serial
    lot no: 62230449 62081271 62133855 62159156 62047629 62127760 61903333 62261628 61830478 61830479 62138082 62230452 61800380 61800381
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Product 7 consists of all products under product code HWC, and same usage: || Item no: || 47234801435 3.5MM CORT SCR X 14MM || 47234801635 3.5MM CORT SCR X 16MM || 47234806535 3.5MM CORT SCR X 65MM || 47234807035 3.5MM CORT SCR X 70MM || 47234807535 3.5MM CORT SCR X 75MM || 47234808035 3.5MM CORT SCR X 80MM || 47234808535 3.5MM CORT SCR X 85MM || 47234809035 3.5MM CORT SCR X 90MM || 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
    All lots. Lots 00111134, 60747593, 60747594, 60752676, 60752677, 60760248, 60768076, 60821507, 60824004, 60830411, 60830412, 60845351, 60850604, 60852670, 60852671, 60860895, 60866613, 60872311, 60879050, 60892605, 60900745, 60907449, 60917234, 60922494, 60938889, 60938890, 60947027, 60947028, 60963035, 60963036, 60963037, 60963039, 60983254, 61015851, 61028168, 61033723, 61033724, 61068387, 61068388, 61068389, 61074754, 61074755, 61084771, 61096604, 61116246, 61116247, 61137056, 61143427, 61149041, 61157940, 61173295, 61193516, 61193520, 61198179, 61204038, 61215644, 61225562, 61235612, 61240323, 61248321, 61259184, 61263170, 61272449, 61285508, 61298201, 61306497, 61280371, 61315873, 61319581 and 61329266.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Saudi Arabia, Spain, Sweden, Switzerland and the United Kingdom.
  • Descripción del producto
    Zimmer NexGen Complete Knee Solution Minimally Invasive Solutions Procedures Trabecular Metal Technology Tibial Tray, fixed bearing, size 8, sterile, Zimmer, Warsaw, Indiana; REF 00-5954-057-02. || The product is used as an implant for knee replacement.
  • Manufacturer
  • Modelo / Serial
    lot # 60869302 and lot # 60963801
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
  • Descripción del producto
    Zimmer Reconstruction System Tenaculum Left Tine Straight 9 inch, Item # 00-1179-021-00, Zimmer Inc., Warsaw, IN. || Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
  • Manufacturer
  • Modelo / Serial
    lot #'s: 60544910, 60750863 and 60902482
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
  • Descripción del producto
    Zimmer Reconstruction System Tenaculum Right Tine Straight 9 inch, Item # 00-1179-022-00, Zimmer Inc., Warsaw, IN. || Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
  • Manufacturer
  • Modelo / Serial
    lot #'s: 60806992 and 60921166
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
  • Descripción del producto
    Zimmer Reconstruction System Tenaculum Straight Tine Straight 9 inch, Item # 00-1179-023-00, Zimmer Inc., Warsaw, IN. || Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
  • Manufacturer
  • Modelo / Serial
    lot #'s: 60636760, 60723667 and 60896770.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
  • Descripción del producto
    Zimmer Reconstruction System Tenaculum 9 inch Length, One 3.5 mm Screw Tine, Item # 00-1179-024-00, Zimmer Inc., Warsaw, IN. || Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
  • Manufacturer
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