Ant-Cer Dynamic Cervical Plating System Literature. Device is manufactured by Spinal Concepts, Austin, TX
FDA device recall Z-1038-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Spinal Concepts, Inc
- Reason for recall
- Recall of product literature that describes use of the device.
- Action taken
- 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
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 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
- Date initiated
- 2004-03-08
- Date posted
- 2004-07-20
- Date terminated
- 2007-04-13
- Location
- Austin, TX
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM (K024326) | Spinal Concepts, Inc. | 2003-01-23 |