Device Recall Zimmer

  • Modèle / numéro de série
    lot no.: 61895477 62274946 61771936 61859733 61895479 62049380 62274957 62274957N 61879883 61771950 61879872 61879874 61918348 61944990 62199039 62312399 62312401 62312402 62312401N 61859738 61944992 62124572 62124572N 61941119 62296602 62233795 62312404 62312404N 61944994 62134044 61771903 62152982 61941121 61944995 62233794 62233796 62296608 61771908 62180987
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Product 58 consists of all product under product code: HRS and same usage: || Item no: || 234800904 PROXIMAL DORSAL ULNA PLT || 234800906 PROXIMAL DORSAL ULNA PLT || 234800908 PROXIMAL DORSAL ULNA PLT || 234800910 PROXIMAL DORSAL ULNA PLT || 234801004 PROXIMAL DORSAL ULNA PLT || 234801006 PROXIMAL DORSAL ULNA PLT || 234801008 PROXIMAL DORSAL ULNA PLT || 234801010 PROXIMAL DORSAL ULNA PLT 10H LT || 234701304 PROXIMAL MEDIAL TIBIAL 4. || 234701306 PROXIMAL MEDIAL TIBIAL 4. || 234701308 PROXIMAL MEDIAL TIBIAL 4. || 234701404 PROXIMAL MEDIAL TIBIAL 4. || 234701406 PROXIMAL MEDIAL TIBIAL 4. || 234701408 PROXIMAL MEDIAL TIBIAL 4. || 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

Fabricant

  • Adresse du fabricant
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    All lots in distribution prior to 5/8/17
  • Distribution
    Nationwide Worldwide
  • Description du dispositif
    Reusable instruments in the Knee, Hip, Trauma, and Extremities segments.
  • Manufacturer
  • Modèle / numéro de série
    Lot Numbers: 63399406, 63399407, 63413258, 63418122, 63419454, 63421749, 63471169, 63471170, 63471171, 63474753, 63474754, 63484232, 63501370, 63633540, 63649266 & 63655091.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • Description du dispositif
    Zimmer Trabecular Metal(TM) Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, Sterile
  • Manufacturer
  • Modèle / numéro de série
    Lot Numbers: 63574373, 63622721, 63398756, 63415316, 63444654, 63462301, 63474169, 63485122, 63485126, 63496894, 63505359, 63530405 & 63530406
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • Description du dispositif
    Zimmer Periarticular Locking Plate System Locking Screw Tap Standard Quick-Connect, 2.7 mm Diameter, Item Number/EDI 00236015327, Nonsterile
  • Manufacturer
  • Modèle / numéro de série
    Lot Numbers: 63584061 & 63634136
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • Description du dispositif
    Zimmer Natural Nail System Calibrated Drill Long 4.3mm, Item Number/EDI 00249004443, Nonsterile
  • Manufacturer
  • Modèle / numéro de série
    Lot Numbers: 63578494, 63641443 & 63524035.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • Description du dispositif
    Zimmer Periarticular Locking Plate System, Locking Screw Tap Standard Quick-Connect 3.5 mm Diameter, Item Number/EDI 00236015335, Nonsterile
  • Manufacturer
258 en plus