Device Recall Pathfinder NXT Closure Top Driver Long

  • Modèle / numéro de série
    REF 3566-1 Lots 62TP, 63SG, 65DE, 66CH.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including states of: AZ, CA, WI, MI, KS, OK, TX, GA, TN, FL, NJ, CT, PA and the countries of: Australia and Italy.
  • Description du dispositif
    Pathfinder NXT Closure top driver - long, REF 3566-1, Zimmer Inc., Warsaw, IN || Product Usage: The Closure Top Driver is used in conjunction with compressors, distractors, and reducers, as needed, to manipulate and hold the spine into the desired position via loosening/tightening maneuvers on the provisionally inserted closure tops of the construct assembly. After confirmation of correct screw and rod placement, the Closure Top Driver is used to apply final torque to the provisionally tightened closure tops to secure the construct assembly. The Closure Top Driver is also used to remove previously inserted closure tops during construct removal.
  • 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