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Terminated

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

FDA Recall Z-0935-2009 · Posted 2009-01-28

Recalling FirmDavol, Inc., Sub. C. R. Bard, Inc.
Recall StatusTerminated
Product CodeFTL
Date Initiated2008-12-08
Date Terminated2012-05-02
Product Quantity232 units

Reason for Recall

Mislabeled: Product labeled as Left large, may contain a Right Large

Firm 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.

Root Cause

Mixed-up of materials/components

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K792281USHER'S MARLEX TUBULAR MESHDavol, Inc. · 1979-11-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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