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/ Manufacturer |
Davol, Inc., Sub. C. R. Bard, Inc. 100 Crossings Blvd Warwick RI 02886-2850
|
For Additional Information Contact |
SAME 401-463-7000
|
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.
|