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
This recall has been terminated (originally issued January 28, 2009).
- Recall Initiated
- December 8, 2008
- Posted
- January 28, 2009
- Terminated
- May 2, 2012
- Recall Number
- Z-0935-2009
- Quantity
- 232 units
- Firm Location
- Warwick, RI
- Official Source
- View on FDA website ↗
Reason for Recall
Mislabeled: Product labeled as Left large, may contain a Right Large
Distribution
Nationwide
Lot / Code Info
Lot Code: 43JQD016
Root Cause
Mixed-up of materials/components
Action Taken
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.
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