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U.S. Department of Health and Human Services

Class 3 Device Recall Bard/Davol

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  Class 3 Device Recall Bard/Davol see related information
Date Initiated by Firm December 08, 2008
Date Posted January 28, 2009
Recall Status1 Terminated 3 on May 02, 2012
Recall Number Z-0935-2009
Recall Event ID 50479
510(K)Number K792281  
Product Classification Surgical mesh - Product Code FTL
Product Bard 3D Max Mesh, Left large , Sterile
Pre-formed Knitted Polypropylene
Product Code: 0151531
Bard 3D Max Mesh is an anatomically shaped pre-formed polypropylene mesh indicated for use in the repair of hernias and chest wall defects. It is designated in two orientations - "Right" and "Left" for use to the right or left side of the human body. There is a blue monofilament Medial marker "M" and a small arrow stitched into each orientation to designate the right or left medial edge of the product
Code Information Lot Code: 43JQD016
Recalling Firm/
Davol, Inc., Sub. C. R. Bard, Inc.
100 Crossings Blvd
Warwick RI 02886-2850
For Additional Information Contact SAME
Manufacturer Reason
for Recall
Mislabeled: Product labeled as Left large, may contain a Right Large
FDA Determined
Cause 2
Mixed-up of materials/components
Action Davol issued a letter notification dated 12/25/08 via Federal Express requesting accounts discontinue use, remove product from inventory and return product. For additional information, contact Davol at 1-401-463-7000.
Quantity in Commerce 232 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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FTL and Original Applicant = DAVOL, INC.