Z-0525-06

Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 10.8'' x 13.7'' (25.4cm x 33cm) Code: 0010207

Name: Z-0525-06 Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 10.8'' x 13.7'' (25.4cm x 33cm) Code: 0010207
Creator: Davol, Inc., Sub. C. R. Bard, Inc.
Published: 2005-12-22
License: https://open.fda.gov/license/

Davol Inc., Sub. C.R. Bard, Inc. / initiated 2005-12-22 / Completed

FDA source

Davol, Inc., Sub. C. R. Bard, Inc. began a recall of Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 10.8'' x 13.7'' (25.4cm x 33cm) Code: 0010207 on 2005-12-22. The reason FDA records is "Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-0525-06
Status: Completed
Initiated: 2005-12-22
Posted: 2006-02-22
Recalling firm: Davol Inc., Sub. C.R. Bard, Inc.
Product: Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 10.8'' x 13.7'' (25.4cm x 33cm) Code: 0010207
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula
FDA root cause: Other
Action: Davol Inc. notified US Customers by letter on 12/27/05 via Federal Express. Bard Regulatory International was notified 12/22/05 to recall to accounts outside the US. Accounts are requested to return recalled product. A second letter issued dated January 5, 2006 to include additional product codes not identified in the first letter, specifically to the accounts that received those lots. On 3/24 / 06, Davol issued a third Recall Notification for the extended recall to Hospitals and Distributors and a Dear Doctor Letter to Chief of Surgery.
Quantity in commerce: 31,761 units
Distribution: Nationwide Foreign: Australia, Canada, Japan,
Product codes and lots: Lot Codes: 41XMXXXX ¿ M = 2002, 41XNXXXX ¿ N = 2003, 43XMXXXX ¿ M = 2002, 43XNXXXX ¿ N = 2003, 43XOXXXX ¿ O = 2004, 43XPXXXX ¿ P = 2005. If the lot number does not contain either M, N, O or P as the 4th character the lot is not affected by this recall.

Product code FTL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)