FDA Medical Device Recalls (openFDA)
Spinal Concepts, Inc: Ant-Cer Dynamic Cervical Plating System Literature. Device is manufactured by Spinal Concepts, Austin, TX
- Recall number
- Z-1038-04
- Recalling firm
- Spinal Concepts, Inc
- Product
- Ant-Cer Dynamic Cervical Plating System Literature. Device is manufactured by Spinal Concepts, Austin, TX
- Status
- Terminated
- Initiated
- 2004-03-08
- Posted
- 2004-07-20
- Terminated
- 2007-04-13
- Reason
- Recall of product literature that describes use of the device.
- 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
- 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
- Lot, serial or model codes
- All literature
- 510(k) numbers
- ["K024326"]
- PMA numbers
- not on file
- Product code
- KWQ
- Firm FEI
- 3000718496
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28