IN THE HEADLINES:






Kugel Mesh Recall Notices and Affected Device List

 

Product Code

Description

Lot Numbers Recalled

Date Recalled

0010206

Bard ® Composix ® Kugel Extra Large Oval, 8.7" x 10.7"

All Lot Numbers

December 2005 and January 2006

0010207

Bard ® Composix ® Kugel Extra Large Oval, 10.8" x 13.7"

All Lot Numbers

December 2005 and January 2006

0010208

Bard ® Composix ® Kugel Extra Large Oval, 7.7" x 9.7"

All Lot Numbers

December 2005 and January 2006

0010209

Bard ® Composix ® Kugel Oval, 6.3" x 12.3"

All Lot Numbers

March, 24, 2006

0010202

Bard ® Composix ® Kugel Large Oval, 5.4" x 7"

All Lot Numbers

March 24, 2006 and updated Jan. 11, 2007

0010204

Bard ® Composix ® Kugel Large Circle, 4.5"

All Lot Numbers

March 24, 2006 and updated Jan. 11, 2007

0010203

Bard ® Composix ® Kugel Small Circle, 7.6 cm cm

 

not-recalled to date however defects have been reported and claims are being evaluated

0010201

Bard ® Composix ® Kugel Small Oval, 8 cm x 12 cm

 

not-recalled to date however defects have been reported and claims are being evaluated

0010205

Bard ® Composix ® Kugel Medium Oval, 11 cm x 14 cm

 

not-recalled to date however defects have been reported and claims are being evaluated

Use:

The Composix® Kugel Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a "memory recoil ring" that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.

Recalling Firm:

Davol, Inc., Sub. C.R. Bard, Inc.
100 Sockanossett Crossroad
Cranston, RI 02920

Reason for Recall:

The "memory recoil ring" that opens the Composix® Kugel Mesh Patch can break under the stress of placement of the large sized products in the intra-abdominal space. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).

FDA Comments:

  • Surgeons and hospitals should stop using the recalled product and return unused units to the company.
  • Patients who have who have been implanted with one of the recalled devices 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.
  • Davol, Inc. (a subsidiary of C.R. Bard) notified U.S. customers of the 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 clarifying the proper insertion technique and Supplemental Patient Management Information