U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
원인
Aesculap implant systems, llc initiated a recall of the aesculap prospace peek 5 degree implant - 8 x 8.5 x 22 mm (sn038p) because the device is incorrectly etched with an 8 degree lordosis instead of a 5 degree lordosis. the device is labeled correctly, only the etching of the implant may be incorrect.
조치
Aesculap notified customers via email and phone on June 18, 2013, and were instructed to check their inventory and return affected product to Aesculap.
Aesculap believes that the risk to patient is low.
For further questions please call 1-800-234-9179.
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.