FDA Medical Device Recalls (openFDA)
Davol, Inc., Sub. C. R. Bard, Inc.: Bard Composix Kugel Hernia Patch- Large Oval with ePTFE , 5.4'' x 7.0'' Product Number: 0010202
- Recall number
- Z-0359-2007
- Recalling firm
- Davol, Inc., Sub. C. R. Bard, Inc.
- Product
- Bard Composix Kugel Hernia Patch- Large Oval with ePTFE , 5.4'' x 7.0'' Product Number: 0010202
- Status
- Completed
- Initiated
- 2007-01-10
- Posted
- 2007-01-30
- Terminated
- not on file
- Reason
- PET recoil ring breakage-Memory recoil ring may break which could potentially lead to bowel perforation and or chronic enteric fistula
- 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
- 32,581 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Recalled Lot Numbers: 43AOD 43LOD 43BOD 43APD 43COD 43BPD 43DOD 43CPD 43EOD 43DPD 43FOD 43EPD 43GOD 43FPD 43HOD 43GPD 43IOD 43HPD 43JOD 43IPD 43KOD; Market Wthdrawal Lot Numbers: 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.
- 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
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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