• Modèle / numéro de série
    lot no.: 61674472 61906696 62016799 62332483 61674473 61902194 61906697 62326386 61674476 61953546 62161131 62172656 62326385 61953547 62011539 62017894 62130757 61886072 61953548 62017895 62172659 61886073 61948763 61953551 62172661 61874793 61948764 61996232 62017897 62172663 61874794 61953554 62286122
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Product 33 consists of all product under product code: JDI and same usage: || Item no: || 662406515 HGP II ACETABULAR CUP BON || 662406520 HGP II ACETABULAR CUP BON || 662406525 HGP II ACETABULAR CUP BON || 662406530 HGP II ACETABULAR CUP BON || 662406535 HGP II ACETABULAR CUP BON || 662406540 HGP II ACETABULAR CUP BON || 662406550 HGP II ACETABULAR CUP BON || 662406560 HGP II ACETABULAR CUP BON || For use in total 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
    Lot P020077.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    The product was shipped to Hawaii, New York, South Carolina, and South Dakota in the United States.
  • Description du dispositif
    Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica Anterior Cervical Plating Instrument sets (catalog numbers 07.00215.001 and 07.00546.001). Only the Trinica Bone Tap Instruments are being recalled from the sets.
  • Manufacturer
  • Modèle / numéro de série
    Lots 60244776, 60254445, 60270467, 60278638, 60298344, 60317739, 60330363 and 60342788.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • Description du dispositif
    Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Left, 45 degrees, non-sterile; Part number 00-7712-035-01.
  • Manufacturer
  • Modèle / numéro de série
    Lots 60244777, 60254446, 60259343, 60280558, 60295662, 60298480, 60307612, 60333170 and 60336853.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • Description du dispositif
    Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; Part number 00-7712-035-02.
  • Manufacturer
  • 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
258 en plus