Recall Z-1038-04 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Spinal Concepts, Inc
Ant-Cer Dynamic Cervical Plating System Literature. Device is manufactured by Spinal Concepts, Austin, TX
| Date | Jul 20, 2004 (initiated Mar 8, 2004) |
| Status | Terminated |
| 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 c |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024326 | SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM Spinal Concepts, Inc., Jan 23, 2003 |