Device Recall ECT Internal Fracture Fixation Drill

  • Model / Serial
    Lot Numbers: 63545287, 63315176, 63315178, 63315180, 63319001,  63333734, 63333736, 63333737, 63333795, 63333799, 63340564,  63340568, 63347076, 63350788, 63358204, 63384635, 63415299, 63415303, 63426466, 63426492, 63457631, 63457779, 63457780, 63457781, 63457949, 63469913, 63469915, 63469917, 63469919, 63474421, 63478996, 63518027, 63518029 & 63518031.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    ECT Internal Fracture Fixation Drill 2.5 mm Diameter (.098 Inch), Item Number/EDI 00231802500, Nonsterile
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Numbers: 63574373, 63622721, 63398756, 63415316, 63444654, 63462301, 63474169, 63485122, 63485126, 63496894, 63505359, 63530405 & 63530406
  • Product Classification
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    ECT Internal Fracture Fixation Drill 1.1 mm Diameter (.043 Inch), Item Number/EDI 00231801100, Nonsterile
  • Manufacturer
  • Model / Serial
    Lot Numbers: 63562129, 63578148, 63377521, 63398755, 63415317, 63431736, 63438195, 63438272, 63444661, 63462322, 63474385, 63485128, 63497202, 63505360, 63510813, 63524432 & 63530407.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    ECT Internal Fracture Fixation Drill Bits 1.1 mm Diameter, Item Number/EDI 00231801106, Nonsterile
  • Manufacturer
  • Model / Serial
    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
  • Product Classification
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    ECT Internal Fracture Fixation Drill 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801500, Nonsterile
  • Manufacturer
  • Model / Serial
    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.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    ECT Internal Fracture Fixation Drill Bits 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801506, Nonsterile
  • Manufacturer
  • Model / Serial
    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.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    ECT Internal Fracture Fixation Drill 2.0 mm Diameter (.079 Inch), Item Number/EDI 00231802000, Nonsterile
  • Manufacturer
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