Bard® Composix® Kugel® Mesh Patch
In December 2005, the Food and Drug Administration, along with Davol, Inc., a subsidiary of C.R. Bard, Inc. and a market leader in mesh prosthetics for hernia repair, issued an initial recall of Bard® Composix® Kugel® Mesh Patches. Davol expanded this recall in March 2006 and again in January 2007 to include larger numbers of defective patches.
The Bard® Composix® Kugel® Mesh Patch was recalled after reports showed that the “memory recoil ring,” which opens the patch after it has been inserted into the intra-abdominal space, can break under stress. Over 75,000 defective patches were sold.
The Composix Kugel Mesh Patch is used to repair hernias that are caused by the stretching and thinning of scar tissue that forms after surgery. Bard advertises its patch as being superior to other hernia patches as the result of its patented “memory recoil ring” that enables the patch to be folded into a smaller product at the time of insertion, requiring a smaller surgical incision. Due to defects in Bard’s design and manufacturing, the “memory recoil ring” can break during placement. The ring can then come loose inside the intra-abdominal space, causing such injuries as: intestinal perforations; ring migration through the abdominal wall; abscesses; bowel obstruction; sepsis; and chronic intestinal fistulae.
Only certain product codes and lot numbers of the Bard® Composix® Kugel® Mesh Patches are recalled. Our attorneys can help determine if your patch is one of them. If you or a loved one have suffered medical complications as a result of the placement of a Bard® Composix® Kugel® Mesh Patch, the attorneys at Goldenberg & Johnson, PLLC can answer any questions you have and discuss your potential case. You can speak with one of our attorneys at (800) 279-6386.
Recalled Bard Composix Kugel Mesh Patches |
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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" |
All Lot Numbers manufactured before October 2005 |
January 10, 2007 |
|
0010204 |
Bard Composix Kugel Large Circle, 4.5" |
All Lot Numbers manufactured before October 2005 |
January 10, 2007 |
























