Medical Device:

Composix Kugel Mesh X-Large Patch

Manufactured by Davol Inc., the Composix Kugel Mesh Patch was removed from the market in Dec. 2005. The patch was used for ventral or incisional hernias. The product was recalled after learning that the memory recoil ring, which opens the patch after it has been inserted into the intra-abdominal space, can break. If the memory recoil ring breaks, it can cause serious life-threatening complications including chronic intestinal fistulae, bowel perforation and abnormal connections of passageways between intestines and other gastrointestinal organs.

The FDA labeled this recall as Class I, meaning there is reasonable probability that the use of the patch will cause serious injury or death.