Z-1038-04

Ant-Cer Dynamic Cervical Plating System Literature. Device is manufactured by Spinal Concepts, Austin, TX

Name: Z-1038-04 Ant-Cer Dynamic Cervical Plating System Literature. Device is manufactured by Spinal Concepts, Austin, TX
Creator: Spinal Concepts, Inc
Published: 2004-03-08
License: https://open.fda.gov/license/

Spinal Concepts, Inc. / initiated 2004-03-08 / Terminated

FDA source

Spinal Concepts, Inc began a recall of Ant-Cer Dynamic Cervical Plating System Literature. Device is manufactured by Spinal Concepts, Austin, TX on 2004-03-08. The reason FDA records is "Recall of product literature that describes use of the device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1038-04
Status: Terminated
Initiated: 2004-03-08
Posted: 2004-07-20
Terminated: 2007-04-13
Recalling firm: Spinal Concepts, Inc.
Product: Ant-Cer Dynamic Cervical Plating System Literature. Device is manufactured by Spinal Concepts, Austin, TX
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: Recall of product literature that describes use of the device.
FDA root cause: Other
Action: A product caution letter was faxed to each distributor beginning March 9. The fax was followed by a Federal Express delivery of the document beginning March 9.
Quantity in commerce: Unknown. The amount of literature actually distributed to the field is not controlled. Distributors are able to make copies of documents.
Distribution: Tennessee, Michigan, Washington, Kentucky, California, Colorado, Ohio, Oregon, Kansas, Texas, New York, Virginia, Florida, Virginia, New Mexico, Minnesota, Louisiana, Wisconsin, Oklahoma, Pennsylvania, North Carolina, Maryland, Arizona, Utah, Missouri, South Dakota, Illinois, and New Jersey
Product codes and lots: All literature

Product code KWQ

K024326Class IISpinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate SystemSpinal Concepts, Inc. / cleared 2003-01-23

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)