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Sources: EU EUDAMED, US FDA
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Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement. Do not reuse. Ethylene Oxide Sterilized. Made in the U.S.A. Synovis Surgical Innovations A division of Synovis Life Technologies, Inc., 2575 University Ave. W., St. Paul, MN 55114-1024 USA.
FDA Recall
Terminated
·Synovis Surgical Inovation Div. of·Product code FTM·November 1, 2005
XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 19 x 28 cm Rectangle Catalog #: 1161928
FDA Recall
Terminated
·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTM·January 7, 2011
Gynecare PROLIFT Total Pelvic Repair System PFRT01 Ethicon Deutschland
FDA Recall
Terminated
·Ethicon, Inc. US·Product code FTM·April 20, 2007
Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, (PSD 28-U-V), 28mm, US Surgical Staplers. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip
FDA Recall
Terminated
·Synovis Surgical Inovation Div. of·Product code FTM·March 16, 2007
SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25cm, 10x15cm Semi-Oval,
FDA Recall
Open, Classified
·TEI Biosciences, Inc.·Product code FTM·May 23, 2023
SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16 cm, 1.0 3x3 cm, 1.0 4x7 cm, 1.0 4x12 cm, 1.0 6x16 cm, 1.0 25x40 cm, 1.0 20 x 30 cm, 1.0 8x16 cm, 1.0 4x7 cm Thin, 1.0 5x6 cm Thin, 1.0 3x3 cm Thin, 1.0 0.3x25 cm, 1.0 0.6x25 cm, 1.0 1x25 cm.
FDA Recall
Open, Classified
·TEI Biosciences, Inc.·Product code FTM·May 23, 2023
Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code FTM·February 28, 2024
OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G
FDA Recall
Terminated
·AROA Biosurgery, LTD.·Product code FTM·April 6, 2018
OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G
FDA Recall
Terminated
·AROA Biosurgery, LTD.·Product code FTM·April 6, 2018
Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46374
FDA Recall
Open, Classified
·Cook Biotech, Inc.·Product code FTM·August 7, 2024
Strattice Reconstructive Tissue Matrix for Stoma Reinforcement. 8 cm x 8 cm Packaged in an inner foil pouch inside outer foil pouch tertiary carton. LifeCell Corporation, One Millennium Way, Branchburg, NJ 08876 Strattice is intended for use as a foil tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is used for repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. It is intended for single patient one time use.
FDA Recall
Terminated
·LifeCell Corporation·Product code FTM·July 12, 2010
AMS InteXen LP Collagen Dermal Matrix, REF 72404066. Product Size: 8 x 12 cm. AMS InteXen LP is a sterile non-perforated processed porcine collagen dermal matrix. Sterile EO. American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA. The AMS collagen dermal matric is intended for use in the treatment of hernias where connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, or gastroenterological anatomy.
FDA Recall
Terminated
·American Medical Systems·Product code FTM·December 5, 2008
MatriStem Plastic Surgery Matrix XS Intended for implantation to reinforce tissue where weakness exists in urological, gynecological, and gastrointestinal anatomy, including, but not limited to the following procedures: pubourethral support, tissue repair, body wall repair, and esophageal repair
FDA Recall
Terminated
·ACell, Inc·Product code FTM·July 7, 2011
Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
FDA Recall
Open, Classified
·Ethicon, Inc. US·Product code FTM·February 19, 2014
Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code FTM·February 28, 2024
Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603
FDA Recall
Open, Classified
·Cook Biotech, Inc.·Product code FTM·August 7, 2024
Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602
FDA Recall
Open, Classified
·Cook Biotech, Inc.·Product code FTM·August 7, 2024
OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G
FDA Recall
Terminated
·AROA Biosurgery, LTD.·Product code FTM·April 6, 2018
OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G
FDA Recall
Terminated
·AROA Biosurgery, LTD.·Product code FTM·April 6, 2018
OviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822G
FDA Recall
Terminated
·AROA Biosurgery, LTD.·Product code FTM·April 6, 2018