An FDA Class 1 recall is the most urgent type of recall. The Gold Standard, Monofilament, Polypropylene Mesh. C.R. This process “fast tracks” a product to market by giving quick approval to medical products when the company … Because C.R. There have been recalls for these Bard hernia mesh devices. Recall Status 1: Terminated 3 on June 06, 2016: Recall Number: Z-1649-2010: Recall Event ID: 54884: Product Classification: Mesh, surgical, polymeric - Product Code FTL: Product: Bard Mesh Monofilament Knitted Polypropylene; size 3" x 6", 3 units per box. 4 13. Bard was, at all times relevant hereto, responsible for the actions of Davol and ... PerFix Plug, Cat No. The Bard PerFix Plug and the Bard PerFix Light Plug are implantable hernia mesh devices that were made by C.R. In December 2016, that plaintiff had to go through revision surgery, however, to have the Bard Mesh PerFix Plug removed. The recall, issued by the Food and Drug Administration (FDA) was a Class 1 recall, the highest level of … Approximately 8,000 cases are pending against Bard in Rhode Island state court. HUXF0920 was implanted in Plaintiff during this repair. Bard was subject to recalls for Composix Kugel mesh products due to safety concerns about the plastic which would splinter and migrate away from the surgical site. A Bard Perfix Plug lawsuit alleges that the hernia mesh cut off the flow of blood and sperm to and from a man's testicles after it migrated out of position, resulting in the need for revision surgery. Bard ® Mesh reinforces the weakened area, allowing for tissue ingrowth and resiliency. Bard Hernia Mesh FDA Warnings and Recalls. Bard like the PerFix and 3DMax devices, and some devices from Covidien like the Parietex ProGrip have all been the subjects of many such reports. Bard ® Mesh can be tailored preoperatively and customized to any unique situation. Bard and other mesh products are Class II medical devices which were approved through the FDA’s 510(k) process. 2013 Hernia Mesh Implant Recalls. Davol Inc. A Subsidiary of C.R. Bard Hernia Mesh Recall. Atrium's C-QUR, certain devices from C.R. With more than 50 years of clinical experience, Bard ® Mesh is the Gold Standard product to be used in a "tension-free" hernia repair technique. Bard.They are used to treat inguinal hernias.However, both devices suffer from many of the same problems that plague other hernia mesh products. Case 6:18-cv-03019-DPR Document 1 Filed 01/18/18 Page 3 of 34. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920. Physiomesh isn't the only hernia mesh product with a number of adverse event reports. 0112760, Lot No. Bard Mesh PerFix Plug. 5. Here are some of the hernia mesh recalls since 2005: 2005 Hernia Mesh Implant Recalls. R. Bard and Davol recalled Composix Kugel mesh products from the market starting in 2005. 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