Date Recall |
December 23, 2005 |
Product: |
ICON Modular Spinal Fixation System |
Use: |
The ICON Modular Spinal Fixation System contains a variety of screws, rods and connectors implanted in and near the patient's spine to immobilize and stabilize spinal segments at the site of spine surgery. |
Recalling Firm: |
Blackstone Medical, Inc. |
Reason for Recall: |
The pedicle (vertebra stem) screws may separate from the screw heads, or from the rods that run between spinal segments. If this happens soon after the surgery, the spine may not fuse properly, and patients may need additional surgery to correct the problem. If not corrected, some patients may experience long-term pain and disability. The potential for injury depends on the specific condition being treated, and the degree of postoperative healing. |
Public Contact: |
Diane M. Johnson |
FDA District: |
New England |
FDA Comments: |
|
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A copy of the company's press release regarding this recall is available at http://www.fda.gov/oc/po/firmrecalls/blackstone04_12.html. |
Updated April 18, 2006
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