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U.S. Department of Health and Human Services

Class 1 Device Recall Davol Composix Kugel Hernia Patch

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 Class 1 Device Recall Davol Composix Kugel Hernia Patchsee related information
Date Initiated by FirmJanuary 10, 2007
Date PostedJanuary 30, 2007
Recall Status1 Completed
Recall NumberZ-0360-2007
Recall Event ID 36990
510(K)NumberK003323 
Product Classification Hernia Patch - Product Code FTL
ProductBard Composix Kugel Hernia Patch- Large Circle 4.5'' with ePTFE Product Code: 0010204
Code Information 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.
Recalling Firm/
Manufacturer		 Davol, Inc., Sub. C. R. Bard, Inc.
100 Sockanossett Crossroad
Cranston RI 02920
For Additional Information ContactRobin Drago
401-463-7000
Manufacturer 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 Determined
Cause 2		Other
ActionDavol 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 Commerce16,603 units
DistributionNationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database510(K)s with Product Code = FTL
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