Z-0360-2007

Bard Composix Kugel Hernia Patch- Large Circle 4.5'' with ePTFE

Name: Z-0360-2007 Bard Composix Kugel Hernia Patch- Large Circle 4.5'' with ePTFE
Creator: Davol, Inc., Sub. C. R. Bard, Inc.
Published: 2007-01-10
License: https://open.fda.gov/license/

Davol Inc., Sub. C.R. Bard, Inc. / initiated 2007-01-10 / Completed

FDA source

Davol, Inc., Sub. C. R. Bard, Inc. began a recall of Bard Composix Kugel Hernia Patch- Large Circle 4.5'' with ePTFE Product Code: 0010204 on 2007-01-10. The reason FDA records is "PET recoil ring breakage-Memory recoil ring may break which could 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-0360-2007
Status: Completed
Initiated: 2007-01-10
Posted: 2007-01-30
Recalling firm: Davol Inc., Sub. C.R. Bard, Inc.
Product: Bard Composix Kugel Hernia Patch- Large Circle 4.5'' with ePTFE Product Code: 0010204
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: PET recoil ring breakage-Memory recoil ring may break which could potentially lead to bowel perforation and or chronic enteric fistula
FDA root cause: Other
Action: Davol Inc. notified Hospital Administrators/Risk Health Managers,distributors, and surgeons of the expanded recall by letter beginning 1/10/07. Product under recall is to be returned to Davol for replacement. Davol is posting recall information to their website.
Quantity in commerce: 16,603 units
Distribution: Nationwide
Product codes and lots: Lot Numbers: 43AOD 43LOD 43BOD 43APD 43COD 43BPD 43DOD 43CPD 43EOD 43DPD 43FOD 43EPD 43GOD 43FPD 43HOD 43GPD 43IOD 43HPD 43JOD 43IPD 43KOD; Market Withdrawal: 43JPD 43DQD 43KPD 43EQD 43LPD 43FQD 43AQD 43GQD 43BQD 43HQD 43CQD 43IQD* *Redesigned products will be clearly indicated on the label. Any product of this lot with the word 'Redesigned' on the label is not part of this Market Withdrawal.

Product code FTL

K003323Class IIComposix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205Davol, Inc. / cleared 2001-01-22

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)