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U.S. Department of Health and Human Services

Class 2 Device Recall Aesculap PEEK Intervertebral Body Fusion System

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 Class 2 Recall
Aesculap PEEK Intervertebral Body Fusion System
see related information
Date Posted July 25, 2013
Recall Status1 Terminated on January 13, 2014
Recall Number Z-1806-2013
Recall Event ID 65703
Premarket Notification
510(K) Number
K071983 
Product Classification Intervertebral Fusion Device With Bone Graft, Lumbar - Product Code MAX
Product 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.
Code Information Part no. SN038P, batch number 51915765
Recalling Firm/
Manufacturer
Aesculap, Inc.
3773 Corporate Pkwy
Center Valley, Pennsylvania 18034-8217
For Additional Information Contact Aesculap Customer Service
800-234-9179
Manufacturer 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.
FDA Determined
Cause 2
TRAINING: 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 in Commerce 9
Distribution US Distribution including the states of NV and MI
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MAX and Original Applicant = AESCULAP IMPLANT SYSTEMS, INC.
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