January 10, 2007
This letter is intended to inform you of actions being undertaken by Davol, a subsidiary of C. R. Bard, Inc., with the Large Sized Composix® Kugel® patches referenced in the header box at the top of this letter. First, we are expanding the recall action to certain manufacturing lots of the referenced product based on having received additional complaint reports of PET recoil ring breakage.
Specific information about this recall action is discussed below. Second, Davol has decided to withdraw from the market all remaining 0010202 and 0010204 product which has the same component design as the manufacturing lots being recalled. An upgraded product design for both product codes is available for replacement.
EXPANDED RECALL ACTION:
Davol is expanding the voluntary recall of specific lots of Bard® Composix® Kugel® Large Oval and Large Circle Patches. Immediately discontinue use of the specific product codes and lot numbers listed in the attachment. Additionally, please immediately distribute copies of the Important Patient Management Information to clinicians who may have implanted, or who may be managing, patients already implanted with one of these products under voluntary recall. This information supplements information contained in the recall letters issued by Davol in December 2005 and January 2006 for the Extra Large Patches and March 2006 for the Large Patches.
Product codes and lot numbers that contain the re-designed product and are not subject to this recall action can easily be identified on the case or unit package with the label stating “Redesigned for improved ring integrity”. If this label is affixed to your case stock and/or individual packages, this product is not affected by this recall and need not be returned to Davol.
Additionally, current product Instructions For Use (“IFU”) are included with this letter as a reminder of the appropriate folding technique to be used for both Open Placement and Laparoscopic Placement for the Large Composix® Kugel® Patches. Additional copies of these IFUs are available from Davol Customer Service by calling 1-800-531-4124.
SUMMARY OF THE PRODUCT RECALL COMMUNICATIONS:
Extension of the previous recall to specific lots of Bard® Composix® Kugel® Patches is being conducted because we have received additional complaint reports for PET recoil ring breakage on lots of product codes 0010202 manufactured from January 1, 2004 through September 30, 2005. That rate of occurrence is defined below. There is a risk that the ring welds could break under stress placed on these products during placement, which could potentially lead to patient complications such as abdominal pain, bowel perforation or chronic enteric fistulas. The products and lot numbers being recalled are listed on the attached Acknowledgement/Stock Status Form, which has been sent to all hospital administrators, risk managers, materials managers, OR managers, and distributors.
Observed Rate of Occurrence and Clinical Implications:
Product Code 0010202, Bard® Composix® Kugel® Large Oval Patch: A total of 6 ring breaks have been reported, and four of these complaints have been confirmed, from the approximately 25,835 units manufactured between January 1, 2004 and September 30, 2005, for a reported occurrence rate of 0.023%.
Incidents:
One (1) Incident occurred during the mesh placement surgery and the product was not implanted.
One (1) incident of a broken ring was noted at the time of surgery and the ring was removed but the mesh was left implanted. No patient symptoms have been reported following this procedure.
One (1) incident was reported where a broken ring had migrated into the abdominal wall and was removed, leaving the mesh implanted.
One (1) incident was reported where the mesh was explanted as a response to reported abdominal pain and a broken ring was noted.
Two (2) inconclusive incidents were reported where bowel perforation and broken rings were noted at the time of explant.
Product Code 0010204, Bard® Composix® Kugel Large Circle: No ring breaks have been reported in this product. However, because of the similarity of the ring joint welding process and PET ring diameter, this product is being recalled as a precaution.
RECOMMENDATIONS:
We realize that each of your patients is unique and we support your clinical judgment in caring for them. Based on our review of reports received to date and the low incidence of patient injury observed to date, Davol believes that the great majority of patients who received any product from these specific lots of Bard® Composix® Kugel® device subject to recall will be asymptomatic with the device functioning as intended. In such cases the risk of leaving the device in place may be less than the risk posed by removing it.
To further assist physicians in their patient care, Davol offers the following recommendations applicable to patients who have been implanted with one of the recalled devices:
Identify: patients who have been implanted with one of the recalled devices;
Communicate: advise patients of this recall and direct them to seek 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;
Examine: symptomatic patients for conditions that could be associated with recoil ring breakage, including bowel obstruction, perforation or fistula, abdominal wall pain or infection, palpable abdominal wall mass, migration or movement of the ring to the abdominal wall, perineum or intra-abdominal organs;
Evaluate: your patient’s condition based on clinical signs and symptoms and using your clinical judgment. Please note that in some cases clinicians have reportedly intervened surgically to remove a broken ring without removing the adherent patch with good success. However, in more serious cases such as bowel obstruction or perforation or serious abdominal wall infection, you may wish to consider removing the entire patch; and
Report: please report any problems that you encounter with this or any other Davol product to our Customer Field Assurance Department at 1-800-556-6756 extension 2438.
If you experience a ring break please return the product to Davol for a complete evaluation. To return the products please follow the instructions in the Acknowledgement/Stock Status Form. If you have questions please contact Davol Customer Service at 1-800-531-4124.
MARKET WITHDRAWAL
Davol has decided to voluntarily withdraw from the market all remaining Bard® Composix® Kugel® Large Oval and Large Circle Patches that have the same component design as the manufacturing lots included in the expanded recall. This includes product manufactured from October 2005 to October 2006. Davol has improved the product component design as described below and has reviewed this strategy with the FDA and received concurrence with this action.
The new product component design is characterized by several important changes in these patches which include –
Change from a 0.042” diameter recoil ring stock to a less rigid 0.030” diameter recoil ring stock (already used on other sizes of Bard® Composix® Kugel® patch).
Increase of the recoil ring weld strength by a factor of four times
Increase of the recoil ring weld overlap at the weld joint from 0.180” to 0.480”
Inclusion of the most current product IFU to provide guidance to preclude inappropriate manipulation during surgical insertion of the product.
Product codes and lot numbers that contain the re-designed product and are not subject to this market withdrawal can easily be identified on the case or unit package with the label stating “Redesigned for improved ring integrity”. If this label is affixed to your case stock and/or individual packages, this product is not affected by this market withdrawal and need not be returned to Davol.
Any adverse reactions or quality problems experienced with use of these products should be reported to the FDA MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md. 20852-9787, or on the MedWatch web site at www.fda.gov/medw
