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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Product Detail

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.
Recall Number Z-1806-2013
Classification Class II
Code Info Part no. SN038P, batch number 51915765
Product Distributed Qty 9
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.

Event Detail

Event Id 65703
Product Type Devices
Status Ongoing
Recalling Firm Aesculap, Inc.
City Center Valley
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-18
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern US Distribution including the states of NV and MI