Devices

Device Recall Ascent

  • Model / Serial
    Lots 061810, 217860, 170830, 195550, 467300, 481550, 450420, 602570, 608410, 576640, 024590, 388080 and 840080.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Austria, Belgium, Canada, Costa Rica, Denmark, Finland, Greece, Israel, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, and the United Kingdom.
  • Product Description
    Biomet Ascent SI knee instruments sliding femoral 4-in-1 block, large, stainless steel; Ref. RD140632.
  • Manufacturer
    Biomet, Inc.
  • 1 Event

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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 Ascent
  • Model / Serial
    Lots 147360, 201140, 310920, 238700, 238710, 397060, 467290, 481540, 523300, 607880, 024490, 560790 and 761870.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Austria, Belgium, Canada, Costa Rica, Denmark, Finland, Greece, Israel, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, and the United Kingdom.
  • Product Description
    Biomet Ascent SI knee instruments sliding femoral 4-in-1 block, x-small, stainless steel; Ref. RD140629.
  • Manufacturer
    Biomet, Inc.
Device Recall Ascent
  • Model / Serial
    Lots 074170, 117920, 117580, 170730, 191880, 232930, 439220, 409710, 441190, 468560, 523310, 608390, 602560, 024500, 278400 and 840090.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Austria, Belgium, Canada, Costa Rica, Denmark, Finland, Greece, Israel, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, and the United Kingdom.
  • Product Description
    Biomet Ascent SI knee instruments sliding femoral 4-in-1 block, small, stainless steel; Ref. RD140630.
  • Manufacturer
    Biomet, Inc.
Device Recall Ascent
  • Model / Serial
    Lots 061800, 300150, 191900, 192030, 542470, 439240, 443030, 481530, 608400, 024540, 278410 and 761860.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Austria, Belgium, Canada, Costa Rica, Denmark, Finland, Greece, Israel, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, and the United Kingdom.
  • Product Description
    Biomet Ascent SI knee instruments sliding femoral 4-in-1 block, medium, stainless steel; Ref. RD140631.
  • Manufacturer
    Biomet, Inc.
Device Recall Ascent
  • Model / Serial
    Lots 117650, 170870, 229660, 238680, 467310, 491720, 608420, 542570, 491721, 024600, 351170 and 561190.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Austria, Belgium, Canada, Costa Rica, Denmark, Finland, Greece, Israel, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, and the United Kingdom.
  • Product Description
    Biomet Ascent SI knee instruments sliding femoral 4-in-1 block, x-large, stainless steel; Ref. RD140633.
  • Manufacturer
    Biomet, Inc.
Device Recall Ascent POCTS (Posterior Occipital Cervical Thoracic System)
  • Model / Serial
    Part Numbers: 65-3310,-3312, -3314, -3318, -3320-, -3322, -3324, -3326, -3328, and -3330; Lot numbers: 009, 010, 011, 018, 019, 031, 048, 064, 084 and 107.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide: USA and countries of China, Cyprus, Turkey and Switzerland.
  • Product Description
    Ascent POCTS (Posterior Occipital Cervical Thoracic System) Part Numbers: 65-33 XX Series (65-3310,-3312, -3314, -3318, -3320-, -3322, -3324, -3326, -3328, and -3330), Multi-Axial Screw, 4.0mm x 26mm;Implant grade Titanium Alloy; Blacksone Medical Inc., 90 Brookdale Drive, Springfield, MA 01104.
  • Manufacturer
    Blackstone Medical, Inc.
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