Aesculap, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1806-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 18, 2013

Date Posted: July 31, 2013

Recall Number: Z-1806-2013

Event ID: 65703

Reason for Recall:

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.

Status: Terminated

Product Quantity: 9

Code Information:

Part no. SN038P, batch number 51915765

Distribution Pattern:

US Distribution including the states of NV and MI

Voluntary or Mandated:

Voluntary: Firm initiated