Device Recall 6hole Pubic Symphysis plate

  • Model / Serial
    Lot number: 383813
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - Costa Rica, Malaysia, Mexico, South Africa, and Spain
  • Product Description
    6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and osteotomies of the pelvic ring. The plates are strategically pre-contoured where beneficial to the application, and they are secured to the bone with || 3.5mm non-locking screws. The Acumed pelvic ring plate is the Pubic Symphysis Plate. || The Acumed Pelvic Plating System is intended for use by surgeons with orthopedic training and knowledge of the indications and techniques required for fixation. The device is to be implanted by the surgeon in a sterile operating room setting.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Acumed LLC, 5885 NW Cornelius Pass Rd, Hillsboro OR 97124-9432
  • Manufacturer Parent Company (2017)
  • Source
    USFDA