Z-0446-2011

BARD Mesh Pre-shaped (1.8" x 4.0"/4.5cm x 10cm)

Name: Z-0446-2011 BARD Mesh Pre-shaped (1.8" x 4.0"/4.5cm x 10cm)
Creator: Davol, Inc., Sub. C. R. Bard, Inc.
Published: 2010-10-15
License: https://open.fda.gov/license/

Davol Inc., Sub. C.R. Bard, Inc. / initiated 2010-10-15 / Terminated / root cause: manufacturing process

FDA source

Davol, Inc., Sub. C. R. Bard, Inc. began a recall of BARD Mesh Pre-shaped (1.8" x 4.0"/4.5cm x 10cm) Product code: 0112700 Intended use: Bard Pre-shaped mesh is a pre-shaped mesh constructed of knitted... on 2010-10-15. The reason FDA records is "Mislabeled: The labeled BARD Mesh Pre-shaped product code 0112700 (1.8" x 4.0"/4.5cm x 10cm), but the contents are the BARD Mesh Large Pre-shaped product code 0113700 (2.4" x 5.4"/6.0cm x 13.7cm)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0446-2011
Status: Terminated
Initiated: 2010-10-15
Posted: 2010-11-23
Terminated: 2011-10-27
Recalling firm: Davol Inc., Sub. C.R. Bard, Inc.
Product: BARD Mesh Pre-shaped (1.8" x 4.0"/4.5cm x 10cm) Product code: 0112700 Intended use: Bard Pre-shaped mesh is a pre-shaped mesh constructed of knitted polypropylene monofilaments. It is indicated for the repair of inguinal hernia defects
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: Mislabeled: The labeled BARD Mesh Pre-shaped product code 0112700 (1.8" x 4.0"/4.5cm x 10cm), but the contents are the BARD Mesh Large Pre-shaped product code 0113700 (2.4" x 5.4"/6.0cm x 13.7cm).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Davol issued an "URGENT MEDICAL DEVICE RECALL" letter on October 15, 2010, via Overnight Delivery to all customers. The letter describes the product, the problem and the action to be taken by the customers. The customers were instructed to immediately examine their inventory and quaratine the product; identify and notify customers they may have further distributed the product to of this recall; contact Davol Customer Service at 1-800-556-6275 for instructions on how to return product, and complete and return the attached EFFECTIVENESS CHECK form via fax to 1-401-825-8753. If you have an questions, please contact Davol Customer Service Department at 1-800-556-6275 or C. R. Bard's Medical Service Support Department at 1-800-562-0027.
Quantity in commerce: 144 units
Distribution: Nationwide distribution
Product codes and lots: Lot : HUUF0412.

Product code FTL

K052155Class IIBard Large Pore Soft Mesh and Soft Mesh PreshapedC.R. Bard, Inc. / cleared 2005-10-20

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)