Device Recall Torque Limiting Handle (Aspen/ Alpine)

  • Modèle / numéro de série
    538133,538134,548080,550475,552169,553131,553710,558873,567568,569141  Part Number: 6200-1109 2009300344 to 2009300543  2009300544 to 2009300643  2009300644 to 2009300743  2009300744 to 2009300843  2009300844 to 2009300993  2009411328 to 2009411377  2010082160 to 2010082257  2010152507 to 2010152571  2010373025 to 2010373174
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Worldwide Distribution - US Nationwide
  • Description du dispositif
    Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 || Product Usage: || Provides posterior fixation in the non-cervical spine with an interspinous fixation device.
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Biomet Spine, LLC, 310 Interlocken Pkwy Ste 120, Broomfield CO 80021-3464
  • 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