Ant-Cer Dynamic Cervical Plating System Literature. Device is manufactured by Spinal Concepts, Austin, TX
FDA Recall Z-1038-04 · Posted 2004-07-20
Advertisement
Recalling FirmSpinal Concepts, Inc
Recall StatusTerminated
Product CodeKWQ
Date Initiated2004-03-08
Date Terminated2007-04-13
Product QuantityUnknown. The amount of literature actually distributed to the field is not controlled. Distributors are able to make copies of documents.
Reason for Recall
Recall of product literature that describes use of the device.
Firm 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.
Root Cause
Other
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement