Recall Z-1806-2013 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Aesculap, Inc.
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 trau
| Date | Jul 25, 2013 (initiated Jun 18, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Employee error |
| Action | 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 | 9 |
| Distribution | US Distribution including the states of NV and MI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071983 | AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE Aesculap Implant Systems, Inc., May 1, 2008 |