181 results
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27ms
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Sources: EU EUDAMED, US FDA
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Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
FDA Recall
Terminated
·Davol, Inc., Subs. C. R. Bard, Inc.·Product code FTL·September 4, 2012
Sterile packaged wound dressing with white and green inner pouch and outer carton labels, labeled in part:''***V.A.C.*** ABDOMINAL DRESSING WITH NON ADHERENT LAYER***Re-Order No. M6275080/5***Manufactured for Corporate Headquarters: KCI USA, Inc., 8023 Vantage Dr., San Antonio, TX 78230 USA***''.
FDA Recall
Terminated
·Kinetic Concepts, Inc·Product code FTL·March 17, 2006
Bard Mesh Monofilament Knitted Polypropylene; size 10 x 14", 3 units per box; Davol Inc., A Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920. Intended as reinforcement of soft tissue where weakness exists.
FDA Recall
Terminated
·Ram Medical Inc·Product code FTL·March 5, 2010
Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7'' x 10.7'' Code: 0010206
FDA Recall
Completed
·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·December 22, 2005
Product is a surgical device packaged in a box which is labeled as Sterile with the following identification: ''PMII PROLENE Mesh Polypropylene Nonabsorbable Synthetic surgical Mesh ETHICON'' Additional infomation including comparisons between authentic Ethicon product and counterfeit are available at the following website: www.ethicon.com
FDA Recall
Terminated
·Q-Med Corporation·Product code FTL·October 30, 2003
Pinnacle Pelvic Floor Repair Kit--Anterior/Apical STERILE, and Pinnacle Pelvic Floor Repair Kit--Posterior STERILE. Boston Scientific, Corp. Indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code FTL·May 10, 2011
Prolene Polyproplyene Mesh, 3'' x 6'', Nonabsorbable Synthetic Surgical Mesh; six packages per box; sterile; product code PMII; Ethicon Inc., Somerville, NJ 08876
FDA Recall
Terminated
·Cardinal Health·Product code FTL·November 3, 2003
PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3''x6'', each mesh in a sealed pouch package, 6 packages per papercard carton. Cartons labeled in part ***ETHICON, INC., a Johnson & Johnson company SOMERVILLE, NEW JERSEY 08876-0151 ***STERILE: Sterility of contents guaranteed unless package has been opened or damaged***
FDA Recall
Terminated
·Owens & Minor Distribution, Inc.·Product code FTL·November 3, 2003
Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"), Warwick, RI Product Code: 0010211 The Ventrio Hernia Patch is a self-expanding non-absorbable, sterile prosthesis, containing two primary layers of monofilament polypropylene mesh stitched with PTFE monofilament to an ePTFE sheet, forming a positioning pocket. The Ventrio Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
FDA Recall
Terminated
·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·April 8, 2010
Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 7.7'' x 9.7'' (19.6cm x 24.6cm) Code: 0010208
FDA Recall
Completed
·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·December 22, 2005
Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 10.8'' x 13.7'' (25.4cm x 33cm) Code: 0010207
FDA Recall
Completed
·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·December 22, 2005
BardVentralex" Hernia Patch Medium Circle with Strap Diameter 6.4cm /2.5",\ Catalog #0010302, lot number HUTL1283. The BardVentralex" Hernia Patch is a self-expanding, non-absorbable, sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric". It is intended for use in all forms of hernia repair requiring reinforcement with a non-absorbable support material
FDA Recall
Terminated
·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·April 11, 2011
SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
FDA Recall
Terminated
·Allergen Medical·Product code FTL·January 8, 2013
TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
FDA Recall
Terminated
·TYRX Inc.·Product code FTL·June 29, 2016
TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
FDA Recall
Terminated
·TYRX Inc.·Product code FTL·June 29, 2016
Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955460G (EU Only)
FDA Recall
Open, Classified
·Davol, Inc.·Product code FTL·April 25, 2023
Bard Composix Kugel Hernia Patch- Large Oval with ePTFE , 5.4'' x 7.0'' Product Number: 0010202
FDA Recall
Completed
·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·January 10, 2007
C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code FTL·July 19, 2013
TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
FDA Recall
Terminated
·TYRX Inc.·Product code FTL·June 29, 2016
SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
FDA Recall
Open, Classified
·Chamberlain Technologies LLC·Product code FTL·August 12, 2022