Device Recall Drill Bit QuickConnect

  • Model / Serial
    Lot Numbers: 63574361, 63596765, 63596770, 63530401 & 63535496.
  • 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
    Drill Bit Quick-Connect 3.2 mm Diameter 145 mm Length, Item Number/EDI 00480614532, 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

9 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Numbers: 63550419, 63556696, 63566195, 63641526, 63326478, 63358155, 63364056, 63462112, 63474138, 63484940, 63492343, 63524330 & 6350361
  • 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
    Drill Bit Quick-Connect 1.1 mm Diameter 60 mm Length, Item Number/EDI 00480606011, Nonsterile
  • Manufacturer
  • Model / Serial
    Lot Numbers: 63570260, 63574325, 63584027, 63451638, 63451640,  63457758, 63457921, 63478937, 63478942, 63478945, 63484951,  63492357, 63496853 & 63510771.
  • 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
    Drill Bit Quick-Connect 1.5 mm Diameter 85 mm Length, Item Number/EDI 00480608515, Nonsterile
  • Manufacturer
  • Model / Serial
    Lot Numbers: 63545255, 63562124, 63566199, 63566218, 63584030, 63398778, 63426469, 63431693, 63431763, 63444579, 63444581, 63444582, 63444584, 63444587, 63451645, 63451647, 63451648,  63451649, 63451651, 63451655, 63462151, 63462166, 63462170, 63462174, 63474142, 63478948, 63484963, 63484966, 63484973, 63492362, 63492363, 63505347, 63505348, 63510772, 63510773 &  63524431.
  • 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
    Drill Bit Quick-Connect 2.0 mm Diameter 100 mm Length, Item Number/EDI 00480610020, Nonsterile
  • Manufacturer
  • Model / Serial
    Lot Numbers: 63545256, 63550424, 63457944, 63462196, 63462201,  63469886, 63474144, 63484983, 63492364, 63496869, 63505349,  63510774 & 63530385.
  • 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
    Drill Bit Quick-Connect 2.7 mm Diameter 100 mm Length, Item Number/EDI 00480610027, Nonsterile
  • Manufacturer
  • Model / Serial
    Lot Numbers: 63545257, 63545258, 63451724, 63451725, 63451728, 63451730, 63451744, 63451747, 63451751, 63451753, 63451754, 63462227, 63478968, 63478972, 63478974, 63485102, 63530392 & 63530394.
  • 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
    Drill Bit Quick-Connect 2.5 mm Diameter 110 mm Length, Item Number/EDI 00480611025, Nonsterile
  • Manufacturer
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