Device Recall ReSolve Halo Open Back Halo Ring

  • Model / Serial
    Lot Number: 08032014
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA including states of CA, GA, FL, MD, MI, MO, & WA and countries of Australia, Cyprus, Germany, Italy, Kuwait, Saudi Arabia, Singapore, South Africa, Spain, United Arab Emirates, and the United Kingdom.
  • Product Description
    ReSolve Halo - Open Back Halo Ring, Model Number: 505300D || The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Ossur Engineering, Inc, 910 Burstein Dr, Albion MI 49224-4011
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Numbers: 08033120, 08040201, 08050204, 08051414, 08060514, 08070706, 08080710, 08091521, 08093027, and 08102723.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA including states of CA, GA, FL, MD, MI, MO, & WA and countries of Australia, Cyprus, Germany, Italy, Kuwait, Saudi Arabia, Singapore, South Africa, Spain, United Arab Emirates, and the United Kingdom.
  • Product Description
    ReSolve Halo - Open Back Halo Ring, Model Number: 505400D || The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury.
  • Manufacturer
  • Model / Serial
    Lot #: 08052718
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA including states of CA, GA, FL, MD, MI, MO, & WA and countries of Australia, Cyprus, Germany, Italy, Kuwait, Saudi Arabia, Singapore, South Africa, Spain, United Arab Emirates, and the United Kingdom.
  • Product Description
    ReSolve Halo - Open Back Halo Ring, Model Number: 510400D || The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury.
  • Manufacturer