Device Recall Zimmer

  • Modèle / numéro de série
    lot no.: 62222763 62240266 62268561 62284487 62294353 62310467 62320160 62346566 61846909 61859930 62028715 62069012 62114832 62237560 62278694 62284486 62298294 62305946 62310463 62330767 62340043 61864095 62028713 62038326 62086042 62100678 62114831 62215704 62284488 62291943 62305945 62311644 62317919 62320157 62320158 62340044 62363364 61866237 62105184 62215705 62268566 62284489 62294354 62303512 62311645 62330768 62065287 62211913 62268563 62284490 62299091 62320161 62333990 62299091N 61885871 62100679 62278695 62303703 62333992 62069011 62280472
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Product 19 consists of all product code: JDI and same usage: || Item no: || 765301101 CEM FEM ST 11X120 NOCOAT || 765301201 CEM FEM ST 12X125 NOCOAT || 765301301 CEM FEM ST 13X130 NOCOAT || 765301401 CEM FEM ST 14X135 NOCOAT || 765301501 CEM FEM ST 15X140 NOCOAT || 765301601 CEM FEM ST 16X145 NOCOAT || 763301300 CEM FEM ST FX 13 X 130 || 763301600 CEM FEM ST FX 16 X 145 || For use in total or hemi hip arthroplasty
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • 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

263 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Lots 08686700 and 08686500.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • Description du dispositif
    Zimmer M/L Taper Rasp Handle, Left, 45 degrees, non-sterile; Part number 83-7712-035-01. Recall Z-0671-06 extended to include this product.
  • Manufacturer
  • Modèle / numéro de série
    Lots 08686600 and 08686800.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • Description du dispositif
    Zimmer M/L Taper Rasp Handle, Right, 45 degrees, non-sterile; Part number 83-7712-035-02. Recall Z-0671-06 extended to include this product.
  • Manufacturer
  • Modèle / numéro de série
    Lots 14865700, 17308800, 17733600, 17733700, 19001400, 24543400 and 25105000.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide, including USA, Argentina, Brazil, Canada, China, England, France, Germany, Guatemala, Israel, Japan, Jordan, Lebanon, Poland, Saudi Arabia, Singapore, Spain, Taiwan, UAE.
  • Description du dispositif
    Zimmer M/DN Intramedullary Fixation 4.2 dia. cortical screw, 3.5 mm hex head, 75 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-75-42 (00225307542).
  • Manufacturer
  • Modèle / numéro de série
    Lots 24667700, 24732400, 24732500, 24732600, 24732700, 25770200, 26003400, 26435500, 60005230, 60019029, 60030638, 60034743, 60034748, 60043067 and 60043311.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide, including USA, Argentina, Brazil, Canada, China, England, France, Germany, Guatemala, Israel, Japan, Jordan, Lebanon, Poland, Saudi Arabia, Singapore, Spain, Taiwan, UAE.
  • Description du dispositif
    Zimmer M/DN Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm hex head, 65 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-65-45 (00225306545).
  • Manufacturer
  • Modèle / numéro de série
    Lots 17035000, 17308200, 17600700, 17733300, 18277400, 19001000, 19148900 and 19149000.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide, including USA, Argentina, Brazil, Canada, China, England, France, Germany, Guatemala, Israel, Japan, Jordan, Lebanon, Poland, Saudi Arabia, Singapore, Spain, Taiwan, UAE.
  • Description du dispositif
    Zimmer M/DN Intramedullary Fixation 4.2 dia. cortical screw, 3.5 mm hex head, 70 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-70-42 (00225307042).
  • Manufacturer
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