Device Recall Sutures, Nonabsorbable, Steel, Monofilament and Multifilament, Sterile

  • Model / Serial
    Product Code: X-4981M4, Lot number: 02J0800451
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
  • Product Description
    Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, || 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 Ushaped; 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

Manufacturer

  • Manufacturer Address
    Teleflex Medical, 2917 Weck Dr., Research Triangle Park NC 27709
  • Manufacturer Parent Company (2017)
  • Source
    USFDA