Device Recall VerSys Femoral Head

  • Modèle / numéro de série
    VerSys¿ Femoral Head -3.5 x 32 mm Diameter: Catalog number 00-8018-032-01; Lot number 61275855.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: USA and countries including Bolivia, Canada, New Zealand, Taiwan, Thailand, Singapore, and India.
  • Description du dispositif
    VERSYS¿ HIP SYSTEM || FEMORAL HEAD 12/14 TAPER 32 MM DIA. -3.5 MM NECK LENGTH || ZIMALOY¿ CO-CR-MO ALLOY STERILE QTY-1 || MANUFACTURED BY ZIMMER MANUFACTURING B.V., || A SUBSIDIARY OF ZIMMER, INC. (WARSAW, IN) || The VerSys¿ Hip System Femoral Heads are intended for use in total hip arthroplasty and are assembled onto the proximal taper of the hip stem. The femoral heads manufactured from Zimaloy Alloy are intended for mating with Tivanium" Ti-6AL-4V Alloy and Zimaloy Alloy femoral stems equipped with taper necks. These femoral heads are available in two Morse-type taper options, 6-degree and 12/14, each of which mates with the corresponding 6 degree or 12/14 taper of a femoral stem prosthesis. Each taper option is supplied in a variety of diameters and neck lengths for use in total hip arthroplasty.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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

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  • Modèle / numéro de série
    VerSys¿ Femoral Head -3.5 x 32 mm Diameter: Catalog number 00-8018-028-01; Lot number 61424803.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: USA and countries including Bolivia, Canada, New Zealand, Taiwan, Thailand, Singapore, and India.
  • Description du dispositif
    VERSYS¿ HIP SYSTEM || FEMORAL HEAD 12/14 TAPER 28 MM DIA. -3.5 MM NECK LENGTH || ZIMALOY¿ CO-CR-MO ALLOY STERILE QTY-1 || MANUFACTURED BY ZIMMER MANUFACTURING B.V., || A SUBSIDIARY OF ZIMMER, INC. (WARSAW, IN) || The VerSys¿ Hip System Femoral Heads are intended for use in total hip arthroplasty and are assembled onto the proximal taper of the hip stem. The femoral heads manufactured from Zimaloy Alloy are intended for mating with Tivanium" Ti-6AL-4V Alloy and Zimaloy Alloy femoral stems equipped with taper necks. These femoral heads are available in two Morse-type taper options, 6-degree and 12/14, each of which mates with the corresponding 6 degree or 12/14 taper of a femoral stem prosthesis. Each taper option is supplied in a variety of diameters and neck lengths for use in total hip arthroplasty.
  • Manufacturer