Device Recall Normed General Instruments

  • Model / Serial
    Lots: 13065 13569 13571
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Single US consignee CO.
  • Product Description
    Normed General Instruments || 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft || The Countersink is an instrument which is used over the guide wire to prepare for adequate space in the cortical bone rim to sink the screw head in to bones/tissues for different Foot, Ankle and Hand implant systems. The instrument is used in several Normed implant systems. The instrument is used to avoid soft tissue irritation
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer Gmbh, Sulzer Allee 8, Winterthur Switzerland
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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