Davol, Inc., Sub. C. R. Bard, Inc.: Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7'' x 10.7'' Code: 0010206

Recall number

Z-0524-06

Recalling firm

Davol, Inc., Sub. C. R. Bard, Inc.

Product

Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7'' x 10.7'' Code: 0010206

Status

Completed

Initiated

2005-12-22

Posted

2006-02-22

Terminated

not on file

Reason

Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula

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

31,761 units

Distribution

Nationwide Foreign: Australia, Canada, Japan,

Lot, serial or model codes

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.

510(k) numbers

["K003323"]

PMA numbers

not on file

Product code

FTL

Firm FEI

1213643

Firm city

Cranston

Firm state

RI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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