Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ProSpace Peek Implant 5 degree x 8.5 x 22 mm Recalled by Aesculap, Inc. Due to Aesculap Implant Systems, LLC initiated a recall of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Aesculap, Inc. directly.
Affected Products
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.
Quantity: 9
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 2 states: MI, NV
About Aesculap, Inc.
Aesculap, Inc. has 22 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report