Z-0935-2009

Bard 3D Max Mesh, Left large , Sterile Pre-formed Knitted Polypropylene

Name: Z-0935-2009 Bard 3D Max Mesh, Left large , Sterile Pre-formed Knitted Polypropylene
Creator: Davol, Inc., Sub. C. R. Bard, Inc.
Published: 2008-12-08
License: https://open.fda.gov/license/

Davol Inc., Sub. C.R. Bard, Inc. / initiated 2008-12-08 / Terminated / root cause: labeling and UDI

FDA source

Davol, Inc., Sub. C. R. Bard, Inc. began a recall of Bard 3D Max Mesh, Left large , Sterile Pre-formed Knitted Polypropylene Product Code: 0151531 Bard 3D Max Mesh is an anatomically shaped pre-formed... on 2008-12-08. The reason FDA records is "Mislabeled: Product labeled as Left large, may contain a Right Large". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0935-2009
Status: Terminated
Initiated: 2008-12-08
Posted: 2009-01-28
Terminated: 2012-05-02
Recalling firm: Davol Inc., Sub. C.R. Bard, Inc.
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
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: Mislabeled: Product labeled as Left large, may contain a Right Large
Root cause tag: labeling and UDI
FDA root cause: 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
Product codes and lots: Lot Code: 43JQD016

Product code FTL

K792281Class IIUsher's Marlex Tubular MeshDavol, Inc. / cleared 1979-11-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)