the fda issued hernia patch recall affects the composix kugel mesh hernia patch
On December 22, 2005, the FDA and Davol/Bard notified healthcare professionals of a class 1 recall of the Bard Composix Kugel Mesh hernia patch (X-Large Patch Oval with ePTFE).
Since this time, the hernia patch recall has twice been expanded by the FDA and Davol.
hernia patch recall
Currently, the following Bard Composix Kugel hernia patches are included in the hernia patch recall.
| Product Code | Description | Lot Numbers Recalled | Date Recalled |
|---|---|---|---|
| 0010206 | Bard Composix Kugel Extra Large Oval (8.7" x 10.7) |
All Lot Numbers manufactured before January 2006 | December 2005 and January 2006 |
| 0010207 | Bard Composix Kugel Extra Large Oval (10.8" x 13.7") | All Lot Numbers manufactured before January 2006 | December 2005 and January 2006 |
| 0010208 | Bard Composix Kugel Extra Large Oval (7.7" x 9.7") |
All Lot Numbers manufactured before January 2006 | December 2005 and January 2006 |
| 0010209 | Bard Composix Kugel Oval (6.3" x 12.3") |
All Lot Numbers manufactured before March 2006 | March, 24, 2006 |
| 0010202 | Bard Composix Kugel Large Oval (5.4" x 7.0") |
Lot Numbers manufactured before October 2005 (see below) | January 10, 2007 |
| 0010204 | Bard Composix Kugel Large Circle 4.5" |
Lot Numbers manufactured before October 2005 (see below) | January 10, 2007 |
For the hernia patch with a product code of 0010202 or 0010204, the hernia patch recall affects:
- all lots with "O" in fourth position
- all lots with "P" in fourth position
- all lots with "Q" in the fourth position and the letters "A" through "I" in the third position
For the hernia patch with a product code of 0010206, 0010207 or 0010208 the hernia patch recall affects:
- all lots with "M" in fourth position
- all lots with "N" in fourth position
- all lots with "O" in fourth position
- all lots with "P" in fourth position
For the hernia patch with a product code of 0010209 the hernia patch recall affects:
- all lots with "M" in fourth position
- all lots with "N" in fourth position
- all lots with "O" in fourth position
- all lots with "P" in fourth position
- all lots with "Q" in the fourth position and the letters "A" through "B" in the third position
reason for hernia patch recall
The "memory recoil ring" that opens the Bard Composix Kugel Mesh Patch can break under the stress of placement of the large sized products in the intra-abdominal (inside the belly area) space. This can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
patient information
Patients who have who have been implanted with one of the recalled hernia patches should seek medical attention immediately if they experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.
free legal consultation
If you or a loved one have been injured by a recalled hernia patch, or if you are experiencing the symptoms associated with hernia patch failure, you may have a claim against the manufacturers of these recalled hernia patches.
Please contact us today by filling out the brief questionnaire, or by calling our toll free number (1-800-898-2034) for a free, no-cost no-obligation evaluation of your case.
