Devices

Device Recall ECT Internal Fracture Fixation Drill

  • Modèle / numéro de série
    Lot Numbers: 63556702, 63593924, 63593925, 63616888, 63340538, 63340539, 63358202, 63358203, 63372868, 63398777, 63478700,  63479007, 63479008, 63479009, 63517947 & 63524439.
  • Classification du dispositif
    Orthopedic Devices
  • 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
    ECT Internal Fracture Fixation Drill 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803200, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
  • 1 Event

Fabricant

Zimmer Biomet, Inc.
  • Adresse du fabricant
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • 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

14 dispositifs médicaux avec un nom similaire

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Device Recall ECT Internal Fracture Fixation Drill
  • Modèle / numéro de série
    Lot Numbers: 63574373, 63622721, 63398756, 63415316, 63444654, 63462301, 63474169, 63485122, 63485126, 63496894, 63505359, 63530405 & 63530406
  • Classification du dispositif
    Orthopedic Devices
  • 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
    ECT Internal Fracture Fixation Drill 1.1 mm Diameter (.043 Inch), Item Number/EDI 00231801100, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall ECT Internal Fracture Fixation Drill Bits
  • Modèle / numéro de série
    Lot Numbers: 63562129, 63578148, 63377521, 63398755, 63415317, 63431736, 63438195, 63438272, 63444661, 63462322, 63474385, 63485128, 63497202, 63505360, 63510813, 63524432 & 63530407.
  • Classification du dispositif
    Orthopedic Devices
  • 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
    ECT Internal Fracture Fixation Drill Bits 1.1 mm Diameter, Item Number/EDI 00231801106, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall ECT Internal Fracture Fixation Drill
  • Modèle / numéro de série
    Lot Numbers: 63610789, 63610790, 63333727, 63340530, 63364066, 63364067, 63384623, 63398757, 63431747, 63444664, 63444666, 63444667, 63444668, 63462334, 63462340, 63474387, 63485135, 63485138, 63485141, 63497203, 63497204, 63507361 & 63540409
  • Classification du dispositif
    Orthopedic Devices
  • 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
    ECT Internal Fracture Fixation Drill 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801500, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall ECT Internal Fracture Fixation Drill Bits
  • Modèle / numéro de série
    Lot Numbers: 63545279, 63610791, 63641572, 63333729, 63333730, 63333732, 63340531, 63364064, 63364065, 63372902, 63384626, 63384629, 63444670, 63444671, 63457776, 63457945, 63462343, 63462344, 63474390, 63497205, 63497206, 63505362, 63510815, 63535517, 63535518 & 63722007.
  • Classification du dispositif
    Orthopedic Devices
  • 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
    ECT Internal Fracture Fixation Drill Bits 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801506, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall ECT Internal Fracture Fixation Drill
  • Modèle / numéro de série
    Lot Numbers: 63545283, 63578152, 63578153, 63584052, 63358182, 63358184, 63364075, 63384616, 63384617, 63384618, 63398734, 63398735, 63415287, 63415288, 63426487, 63426488, 63431725, 63431730, 63438313, 63438315, 63438316, 63438318, 63444673, 63444674, 63444676, 63444677, 63444678, 63444680, 63444681, 63469895, 93468987, 63469898, 63469901, 63499636, 63499638, 63499640, 63499641, 63510882, 63510883, 63510884, 63510885, 63524433, 63535519 & 63535520.
  • Classification du dispositif
    Orthopedic Devices
  • 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
    ECT Internal Fracture Fixation Drill 2.0 mm Diameter (.079 Inch), Item Number/EDI 00231802000, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
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