Hernia Mesh Recall List | TheLawFirm.com

Hernia Mesh Recall List

A Current List Of Recalled Hernia Mesh Devices.

Hernia Mesh Recall List

According to the US Food and Drug Administration (FDA) the following recalls, have been issued for surgical mesh devices:

Tigr Matrix surgical Mesh
Recalling company: Novus Scientific

Recall Initiated: July 19, 2016
Level: Class 2
Status: Terminated December 23, 2016
Reason: Additional warning and additional contraindication Additional contraindication: Not suitable for the repair of direct inguinal hernias
Additional warning: Because TIGR Matrix Surgical Mesh is fully resorbable, it should not be used in repairs where permanent support from the mesh is required

Ventralight Composer Mesh with Echo
Recalling company: Davol, Inc., Subs. CR Bard, Inc.

Recall Initiated: April 24, 2014
Level: Class 2
Status: Terminated December 23, 2015
Reason: “Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.”

Proceed Surgical Mesh
Recalling company: Ethicon, Inc.

Recall Initiated: February 19, 2014
Level: Class 2
Status: Open
Reason: “The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.”

Seriscaffold Surgical Scaffold
Recalling company: Allergan Medical

Recall Initiated: January 8, 2013
Level: Class 2
Status: Terminated July 29, 2013
Reason: “Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured.”

Bard Soft Mesh
Recalling company: Davol, Inc., Sub. CR Bard, Inc.

Recall Initiated: April 25, 2011
Level: Class 2
Status: Terminated October 28, 2011
Reason: “Mislabeling: complaints of product labeled as Bard Soft Mesh 4” x 6” containing Bard Soft Mesh 6” by 6”.”

Bard Ventralex
Recalling company: Davol, Inc., Sub. CR Bard
, Inc.

Recall Initiated: April 11, 2011
Level: Class 2
Status: Terminated October 27, 2011
Reason: “Mislabeled: Bard Medium Ventralex Hernia Patch 6.4cm/2.5” packaged in pre-printed carton identified for a Bard Ventralex Small Circle 4.3cm/1.7”.”

Utosuture Surgipro Polypropylene Mesh Clear 3" X 5" Sterile
Recalling company: Covidien LP

Recall Initiated: December 15, 2010
Level: Class 2
Status: Terminated January 10, 2013
Reason: “Sterility compromised due to breach in sterile barrier.”

Proceed Surgical Mesh
Recalling company: Ethicon, Inc.

Recall Initiated: October 18, 2010
Level: Class 2
Status: Open
Reason: “There is a potential for delamination in one lot of Proceed surgical mesh.”

Bard Mesh Pre-shaped
Recalling company: Davol, Inc., Sub. CR Bard
, Inc.

Date Initiated: October 15, 2010
Level: Class 2
Status: Terminated October 27, 2011
Reason: “Mislabeled: The labeled BARD Pre-shaped 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).”

Ventrio Hernia Patch
Recalling company: Davol, Inc., Sub. CR Bard, Inc.

Date Initiated: April 8, 2010
Level: Class 2
Status: Terminated October 27, 2011
Reason: “Mislabeled: Product labeled as Small Oval (3.1” x. 4.7”) may contain Small Circle (3.0”).”

3D Max Mesh
Recalling company: Davol, Inc., Sub. CR Bard, Inc.

Date Initiated: December 8, 2008
Level: Class 3
Status: Terminated May 2, 2012
Reason: “Mislabeled: Product labeled as Left large, may contain Right Large.” [sic.]

Proceed Surgical Mesh
Recalling company: Ethicon, Inc.

Date Initiated: January 4, 2006
Level: Class 2
Status: Terminated September 28, 2006
Reason: “Lots of Proceed Surgical Mesh may delaminate from the polypropylene mesh during certain hernia repairs. Exposure of the polypropylene layer to the bowel prior to reperitonealization could increase the risk of adhesions and bowel fistulization.”

Composix Kugel Mesh X-Large Patch
Recalling company: Davol, Inc., Sub. CR Bard, Inc.

Date Initiated: December 22, 2005
Level: Class 1
Status: Completed
Reason: “Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula.”

Peri-Strips Dry with Veritas Collagen Matrix Staple Line reinforcement
Recalling company: Synovis surgical

Recall Initiated: May 23, 2005 Level: Class 2 Status: Terminated November 17, 2005 Reason: “Device is contained in 2 pouches. The outer pouch’s seal may be compromised; this may render the exterior of the interior pouch non-sterile.”

Prolene Mesh
Recalling company: Owens and Minor Distribution, Inc.

Recall Initiated: November 3, 2003
Level: Class 2
Status: Terminated on August 3, 2011
Reason: “Counterfeit product is unapproved medical device with associated potential health hazard.”

Prolene Polypropylene mesh
Recalling company: Cardinal Health

Recall Initiated: November 3, 2003
Level: Class 2
Status: Terminated on November 18, 2008
Reason: “Counterfeit mesh product labeled as Ethicon Prolene Polypropylene Mesh, produce code PMII.”

Prolene Mesh
Recalling company: McKesson General Medical Corporation

Recall Initiated: October 31, 2003
Level: Class 2
Status: Terminated August 4, 2011
Reason: “Counterfeit product is unapproved medical device with associated potential health hazard.”

Prolene Mesh
Recalling company: Q-Med Corporation

Recall Initiated: October 30, 2003
Level: Class 2
Status: Terminated July 11, 2012
Reason: “This wholesaler may have distributed some Prolene Mesh Counterfeit product with the Ethicon trademark.”

Veritas Collagen Matrix
Recalling company: Synovis Surgical

Recall Initiated: December 11, 2002
Level: Class 2
Status: Terminated May 28, 2003
Reason: “A gap in the exterior seal may lead to sterility concerns with the interior pouch.”

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Legal Disclaimer: The information in this article is not intended to be used as medical information or diagnosis. The sources of the information presented in the article have been researched and are linked within the article. Please seek out medical advice from a licensed medical professional if you are experiencing a problem with any of the drugs or devices mentioned in this article.