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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 Patch see related information
Date Initiated by Firm January 10, 2007
Date Posted January 30, 2007
Recall Status1 Completed
Recall Number Z-0360-2007
Recall Event ID 36990
510(K)Number K003323  
Product Classification Hernia Patch - Product Code FTL
Product Bard 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 Contact Robin 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
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
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FTL and Original Applicant = DAVOL, INC.
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