Device Recall Ascent

  • Modèle / numéro de série
    Lots 074170, 117920, 117580, 170730, 191880, 232930, 439220, 409710, 441190, 468560, 523310, 608390, 602560, 024500, 278400 and 840090.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    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.
  • Description du dispositif
    Biomet Ascent SI knee instruments sliding femoral 4-in-1 block, small, stainless steel; Ref. RD140630.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Société-mère du fabricant (2017)
  • 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

6 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Lots 147360, 201140, 310920, 238700, 238710, 397060, 467290, 481540, 523300, 607880, 024490, 560790 and 761870.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    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.
  • Description du dispositif
    Biomet Ascent SI knee instruments sliding femoral 4-in-1 block, x-small, stainless steel; Ref. RD140629.
  • Manufacturer
  • Modèle / numéro de série
    Lots 061800, 300150, 191900, 192030, 542470, 439240, 443030, 481530, 608400, 024540, 278410 and 761860.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    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.
  • Description du dispositif
    Biomet Ascent SI knee instruments sliding femoral 4-in-1 block, medium, stainless steel; Ref. RD140631.
  • Manufacturer
  • Modèle / numéro de série
    Lots 061810, 217860, 170830, 195550, 467300, 481550, 450420, 602570, 608410, 576640, 024590, 388080 and 840080.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    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.
  • Description du dispositif
    Biomet Ascent SI knee instruments sliding femoral 4-in-1 block, large, stainless steel; Ref. RD140632.
  • Manufacturer
  • Modèle / numéro de série
    Lots 117650, 170870, 229660, 238680, 467310, 491720, 608420, 542570, 491721, 024600, 351170 and 561190.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    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.
  • Description du dispositif
    Biomet Ascent SI knee instruments sliding femoral 4-in-1 block, x-large, stainless steel; Ref. RD140633.
  • Manufacturer
  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide: USA and countries of China, Cyprus, Turkey and Switzerland.
  • Description du dispositif
    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
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