Device Recall Aesculap PEEK Intervertebral Body Fusion System

  • Model / Serial
    Part no. SN038P, batch number 51915765
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution including the states of NV and MI
  • Product Description
    ProSpace Peek Implant 5 degree x 8.5 x 22 mm || The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Aesculap, Inc., 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • Manufacturer Parent Company (2017)
  • Source
    USFDA