Device Recall Zimmer

  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    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

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
    Lots 61219397, 61228025 and 61277887.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- United States, France, Germany, Italy, Switzerland and United Kingdom.
  • Description du dispositif
    Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, standard, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-00. || The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.
  • Manufacturer
  • Modèle / numéro de série
    Lot 61221481.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- United States, France, Germany, Italy, Switzerland and United Kingdom.
  • Description du dispositif
    Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, tall, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-05. || The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.
  • Manufacturer
  • Modèle / numéro de série
    Lot 61291761.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- United States, France, Germany, Italy, Switzerland and United Kingdom.
  • Description du dispositif
    Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, standard, 0.512" wide, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-10. || The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.
  • Manufacturer
  • Modèle / numéro de série
    Lots 61161115, 61170213, 61219945, 61256543, 61233590 and 61256542.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- United States, France, Germany, Italy, Switzerland and United Kingdom.
  • Description du dispositif
    Zimmer Natural Nail System, Tibial Targeting Guide Handle, small, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-005-00. || The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.
  • Manufacturer
  • Modèle / numéro de série
    Lots 61161122, 61175552, 61217393, 61248664 and 61233593.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- United States, France, Germany, Italy, Switzerland and United Kingdom.
  • Description du dispositif
    Zimmer Natural Nail System, Tibial Targeting Guide Handle, tall, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-005-03. || The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.
  • Manufacturer
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