Devices

Device Recall ECT Internal Fracture Fixation Drill Bits

  • 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
    Orthopedic Devices
  • 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
    Zimmer Biomet, Inc.
  • 1 Event

Manufacturer

Zimmer Biomet, Inc.
  • Manufacturer Address
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • 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

6 devices with a similar name

Learn more about the data here

Device Recall ECT Internal Fracture Fixation Drill Bits
  • Model / Serial
    Lot Numbers: 63562129, 63578148, 63377521, 63398755, 63415317, 63431736, 63438195, 63438272, 63444661, 63462322, 63474385, 63485128, 63497202, 63505360, 63510813, 63524432 & 63530407.
  • Product Classification
    Orthopedic Devices
  • 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
    Zimmer Biomet, Inc.
Device Recall ECT Internal Fracture Fixation Drill Bits
  • Model / Serial
    Lot Numbers: 63535521, 63535522, 63535523, 63535524, 63545285, 63562130, 63578154, 63578156, 63358058, 63358059, 63358060, 63358061, 63364050, 63377480, 63377481, 63377482, 63384605, 63384606, 63384607, 63398721, 63398722, 63398723, 63398724, 63398736, 63398738, 63415279, 63415280, 63415282, 63415283, 63415284, 63415286, 63426490, 63426491, 63431727, 63431728, 63431729, 63438323, 63438326, 63444503, 63444514, 63444682, 63444683, 63444684, 63444685, 63444686, 63457777, 63457946, 63457947, 63457948, 63469905, 63469907, 63510887, 63510888, 63517978, 63517997, 63518010 & 63524434.
  • Product Classification
    Orthopedic Devices
  • 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 2.0 mm Diameter (.079 Inch) , Item Number/EDI 00231802006, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall ECT Internal Fracture Fixation Drill Bits
  • Model / Serial
    Lot Numbers: 63556699, 63556701, 63593922, 63616886, 63630279,  63641603, 63358167, 63372864, 63372865, 63377514, 63377516,  63415331, 63426482, 63431757, 63457850, 63457853, 63457856,  63469884, 63474434, 63479002, 63479004, 63479006 & 63524437.
  • Product Classification
    Orthopedic Devices
  • 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 2.7 mm Diameter (.106 Inch), Item Number/EDI 00231802706, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall ECT Internal Fracture Fixation Drill Bits
  • Model / Serial
    Lot Numbers: 63556703, 63566220, 63593926, 63593928, 63593930, 63630281, 63340536, 63340537, 63347015, 63347018, 63347022, 63347034, 63358186, 63358201, 63372867, 63398739, 63398761, 63398762, 63426475, 63426476, 63426478, 63431754, 63431755,  63457862, 63457863, 63457865, 63457889, 63474135, 63479010,  63479011, 63479013, 63524442, 63524443 & 63524445.
  • Product Classification
    Orthopedic Devices
  • 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 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803206, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall ECT Internal Fracture Fixation Drill Bits
  • Model / Serial
    Lot Numbers: 63556890, 63630297, 63358210, 63431706, 63444526, 63457649, 63457893, 63479021 & 63524448.
  • Product Classification
    Orthopedic Devices
  • 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 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803506, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
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