Device Recall Zimmer

  • Modelo / Serial
    lot no.: 61678184 61839111 61852988 61862260 61875843 61882261 61898918 61974385 61988314 62002243 62002244 62024181 62031621 62090117 62109252 62263147 61875838 61895890 61895891 61912706 62037827 61649744 61660679 61764382 61882257 61887223 61988311 61988312 61988313 62009735 62037784 62090119 62109257 62153293 62160886 62263160 62109261 61396164 61634704 61664774 61777417 61777418 61782841 61782843 61782845 61782848 61810565 61810566 61810567 61810568 61810569 61810570 61810571 61839106 61839107 61839108 61839109 61852999 61853001 61853002 61853005 61875839 61875854 61882265 61887219 61887220 61893994 61894002 61915563 61915564 61915565 61938456 61938457 61938458 61938459 61980692 61980694 61980696 61980698 61985662 61985665 61985670 61985676 62009730 62009731 62009732 62009734 62017442 62017443 62017444 62024184 62024185 62024186 62031633 62038976 62038977 62038978 62090115 62097349 62097351 62097353 62120586 62120587 62120589 62120590 62120593 62134879 62134889 62134890 62150227 62150230 62150231 62153290 62153291 62153292 62160882 62160884 62193769 62193770 62193771 62204429 62204430 62204431 62204432 62204433 62263150 62263153 62263156 62263158 61649748 61782622 61782623 61782839 61810563 61810564 61839110 61852991 61852993 61875841 61875849 61882258 61887216 61887217 61898919 61985648 61985652 61985656 62002245 62002246 62002247 62009728 62009729 62024182 62024183 62031630 62090118 62118596 62134877 62150234
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Product 20 consists of all prod oct under poduct code: KTT and same usage: || Item no: || 47116201900 COMPRESSION SCREW 1/2IN || 47116202300 COMPRESSION SCREW 1-1/2IN || 47116202200 COMPRESSION SCREW 1-1/4IN || 47116202400 COMPRESSION SCREW 1-3/4IN || 47116202100 COMPRESSION SCREW 1IN || 47116202000 COMPRESSION SCREW 3/4IN || Product Usage: || Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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
    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
  • Modelo / Serial
    Model # 01-8507-400-10 & Model # 89-8507-400-10
  • 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 Single Trigger Handpiece. Rx only Made in Switzerland
  • Manufacturer
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