Hernia Patch Recall Information

the fda issued hernia patch affects the composix kugel

bard composix hernia patch 2On December 22, 2005, the FDA and Davol/Bard notified healthcare professionals of a class 1 recall of the Bard Composix Kugel (X-Large Patch Oval with ePTFE).

Since this time, the hernia patch recall has twice been expanded by the FDA and Davol.

Currently, the following Bard Composix Kugel patches are included in the .

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 with a product code of 0010202 or 0010204, the 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 with a product code of 0010206, 0010207 or 0010208 the 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 with a product code of 0010209 the 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

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 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.