Class 2 Device Recall AntCer

• Date Initiated by Firm: March 08, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on April 13, 2007
• Recall Number: Z-1038-04
• Recall Event ID: 28508
• 510(K)Number: K024326
• Product Classification: Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
• Product: Ant-Cer Dynamic Cervical Plating System Literature. Device is manufactured by Spinal Concepts, Austin, TX
• Code Information: All literature
• FEI Number: 3000718496
• Recalling Firm/ Manufacturer: Spinal Concepts, Inc; 5301 Riata Park Ct Bldg F; Austin TX 78727-3436
• For Additional Information Contact: 512-918-2700
• Manufacturer Reason for Recall: Recall of product literature that describes use of the device.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KWQ