Device Recall Zimmer

  • Modèle / numéro de série
    lot no.: 61889945
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Product 13 consists of all product under product code HWC || , and same usage: || Item no: || 47486510002 6.5 X 100 CANC SCREW, 32M || 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
    All lots.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution --- USA and countries of Australia and China
  • Description du dispositif
    Zimmer Trabecular Metal Reverse Shoulder System Base Plate; Catalog/Ref No. 00-4349-038-00.
  • Manufacturer
  • Modèle / numéro de série
    Catalog TMT4B10: Lot 61840378, 61960160, 61967093, 61982587
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA
  • Description du dispositif
    Zimmer Dental Trabecular Metal, TMT4B10 IMP TM 4.1MM MTX FULL,10MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA || The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region.(Catalog TMT indicates textured collar)
  • Manufacturer
  • Modèle / numéro de série
    Catalog # TMT4B11: Lot 61926103, 61960168, 61967139, 61978064, 61989032
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA
  • Description du dispositif
    Zimmer Dental Trabecular Metal, TMT4B11 IMP TM 4.1MM MTX FULL,11.5MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA || The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, Page 4 of 6 especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region.
  • Manufacturer
  • Modèle / numéro de série
    Catalog TMT4B13, lot 61926106, 61960169, 61967140, 61973165, 61985653
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA
  • Description du dispositif
    Zimmer Dental Trabecular Metal, TMT4B13 TM 4.1MM MTX FULL,13 MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA || The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region. TMT catalog # indicates textured collar.
  • Manufacturer
  • Modèle / numéro de série
    Catalog TMM4B10, lot 6197019, 61971479, 61960143, 6180365, 6184063
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA
  • Description du dispositif
    Zimmer Dental Trabecular Metal, TMM4B10 TM 4.1MM MTX FULL,10 MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA || The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region. Catalog TMM indicates machined collar.
  • Manufacturer
258 en plus