||July 25, 2013
||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.
||Part no. SN038P, batch number 51915765
3773 Corporate Pkwy
Center Valley, Pennsylvania 18034-8217
|For Additional Information Contact
||Aesculap Customer Service
|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.
||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.
|Quantity in Commerce
||US Distribution including the states of NV and MI