Expanded Recall/Market Withdrawal of Hernia Repair Patch Recall
Davol also decided to withdraw from the market specific lots of 0010202 and 0010204 manufactured from October 2005 to October 2006. A market withdrawal is a firm’s removal or correction of a distributed product that involves a minor violation or no violation of the law and would not be subject to legal action by the FDA.
**UPDATE**
Davol is withdrawing the following lots:
- All lots with the letter “P” in the fourth position and the letters “J” through “L” in the third position
- All lots with the letter “Q” in the fourth position and the letters “A” through “I” in the third position [For instance, an example of a withdrawn lot number is “43IQD###.”]
Davol notified U.S. customers of the initial recall by letter on 12/27/05 via Federal Express. On March 24, 2006, Bard issued letters to hospitals and health care professionals alerting them to the additional recalled products. The letters included updated Instructions for Use (“IFU”) clarifying the proper insertion technique and Supplemental Patient Management Information.
Davol, Inc. is expanding its earlier recall of the Composix Kugel Patch, which is used to repair ventral hernias that can appear at the site of a prior surgical incision.
The recalled patches have a "memory recoil ring" that allows the patch to be folded for insertion and then once in place, to spring open and lay flat. The problem is that this ring can break, and if that happens, it can cause a bowel perforation or chronic intestinal fistula.
Davol is now notifying health care professionals about an expanded recall and market withdrawal of additional patches that have a similar design. These actions affect Large Oval and Large Circle patches that have this design. Health care providers who have patches from the recalled lots should stop using them immediately.
If you believe you have one of these patches you should contact your doctor immediately. You may also wish to contact an attorney. For a free case review please fill out the form below. An attorney will review your form and may contact you to discuss your claim.
