Date Recall Initiated:
|
January 19, 2001 |
---|---|
Product:
|
Adcon-L and Adcon-T/N sterile |
Use:
|
For use in single-level, posterior, lumbar disk surgeries (laminectomy) where nerve roots are exposed. Used to inhibit post-surgical peridural fibrosis (thickening and scarring of the tissue surrounding the disks of the spine). This device is used by physicians during surgical procedures. It is not a consumer product. |
Recalling Firm:
|
Gliatech, Inc. Cleveland, Ohio |
Reason for Recall:
|
Aluminum particles were seen in jars of Gelfoam (a raw material component recalled on 11/12/00 by its manufacturer, Pharmacia Corporation) used to manufacture Adcon-L. The particles come from the aluminum lid liner of the containers of Gelfoam and fall into the bottle when the lid is opened or resealed. |
Public Contact:
|
Mr. Terry McMahon Regulatory Affairs Consultant Phone: 1-800-943-3200 |
FDA District:
|
Cincinnati, Ohio |
FDA Comment:
|
FDA considers there to be a risk of post operative infections and post operative pain. |
Updated November 5, 2001
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