Device Recall Zimmer

  • Modèle / numéro de série
    lot no: 62230449 62081271 62133855 62159156 62047629 62127760 61903333 62261628 61830478 61830479 62138082 62230452 61800380 61800381
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Product 7 consists of all products under product code HWC, and same usage: || Item no: || 47234801435 3.5MM CORT SCR X 14MM || 47234801635 3.5MM CORT SCR X 16MM || 47234806535 3.5MM CORT SCR X 65MM || 47234807035 3.5MM CORT SCR X 70MM || 47234807535 3.5MM CORT SCR X 75MM || 47234808035 3.5MM CORT SCR X 80MM || 47234808535 3.5MM CORT SCR X 85MM || 47234809035 3.5MM CORT SCR X 90MM || Product Usage: || A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
  • 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 2385941.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Maryland.
  • Description du dispositif
    Zimmer Anatomical Shoulder Prosthesis, Glenoid, Cemented, sterile; REF 01.04214.370.
  • Manufacturer
  • Modèle / numéro de série
    Lot No: 60646894.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide: USA including states of Arizona, California, Florida, Georgia, Indiana, Michigan, New York, North Carolina, and Virginia, and countries of Germany and Japan.
  • Description du dispositif
    Zimmer Minimally Invasive Solutions Technology, Offset Rasp Handle, Left, 45 degrees, non-sterile; REF/Catalog #: 7712-35-01, Zimmer U.K. Ltd., SN3, 4FP, UK
  • Manufacturer
  • Modèle / numéro de série
    Lot No: 60651168 and 60726506.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide: USA including states of Arizona, California, Florida, Georgia, Indiana, Michigan, New York, North Carolina, and Virginia, and countries of Germany and Japan.
  • Description du dispositif
    Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; REF 7712-35-02, Zimmer U.K. Ltd., SN3, 4FP, UK
  • Manufacturer
  • Modèle / numéro de série
    Lot Numbers: 60009294, 60075254, 60101562, 60156041, 60215686, 60271994, 60314032, 60389073, 60440024, 60506573 and 60590575.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide-USA, Australia, Canada, Colombia, Denmark, Dubai, Italy, Japan, Mexico and Singapore.
  • Description du dispositif
    Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF: 00-2550-001-10, 400 ml INF. Cntrl. Kit w/ 3/32" drain, 2.4 mm, 7Fr, PVC, 107 cm, small, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio.
  • Manufacturer
  • Modèle / numéro de série
    All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.
  • Description du dispositif
    Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/8" Drain , 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-020-05.
  • Manufacturer
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