Z-1806-2013Class II

ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or...

Name: Z-1806-2013 ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or...
Creator: Aesculap, Inc.
Published: 2013-06-18
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2013-06-18 / Terminated / root cause: manufacturing process

FDA source

Aesculap, Inc. began a recall of 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... on 2013-06-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1806-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-18
Posted: 2013-07-25
Terminated: 2014-01-13
Recalling firm: Aesculap Inc
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.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 9
Distribution: US Distribution including the states of NV and MI
Product codes and lots: Part no. SN038P, batch number 51915765

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1806-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1806-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-25

Product code MAX

K071983Class IIAesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc. / cleared 2008-05-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)