Mesh, Surgical
FDA product code FTM · Class II (moderate risk) · 21 CFR 878.3300 · General, Plastic Surgery
164510(k) clearances
0PMA approvals
73recalls
Implantimplanted device
Manufacturers
- Cook Biotech, Inc. 20
- TEI Biosciences, Inc. 7
- Bio-Vascular, Inc. 7
- Kensey Nash Corp. 6
- Xylos Corporation 6
- Organogenesis, Inc. 6
- Acell, Inc. 6
- Lifecell Corp. 6
- S. Jackson, Inc. 6
- C.R. Bard, Inc. 5
- TELA Bio, Inc. 4
- Synovis Surgical Innovations 4
- Aziyo Biologics, Inc. 4
- Pm Devices, Inc. 3
- Rti Biologics, Inc. 3
- CryoLife, Inc. 3
- ETHICON, Inc. 3
- DePuy Orthopaedics, Inc. 3
- Alafair Biosciences, Inc. 3
- Tissue Science Laboratories, Plc 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262406 | EluPro Antibiotic-Eluting BioEnvelopeFTM · Special | Boston Scientific | 08/12/2026SE |
| K250598 | Endoform Reconstructive Template - PLGAFTM · Traditional | Aroa Biosurgery , Ltd. | 06/03/2025SE |
| K243595 | OviTex PRS (Long-Term Resorbable)FTM · Special | TELA Bio, Inc. | 12/19/2024SE |
| K233991 | CanGaroo RM Antibacterial EnvelopeFTM · Traditional | Elutia, Inc. | 06/14/2024SE |
| K241126 | OviTex PRSFTM · Special | TELA Bio, Inc. | 05/22/2024SE |
| K223052 | Peri-Guard and Supple Peri-GuardFTM · Traditional | Synovis Life Technologies, Inc. | 04/07/2023SE |
| K214070 | OviTex PRS (Long Term Resorbable)FTM · Traditional | Tela Bio | 03/21/2023SE |
| K213163 | VersaWrapFTM · Special | Alafair Biosciences, Inc. | 10/29/2021SE |
| K213125 | PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…FTM · Special | Synovis Life Technologies. Inc. (A Subsidiary of… | 10/27/2021SE |
| K203496 | Nexo-Gide Bilayer Collagen MembraneFTM · Traditional | Geistlich Pharma AG | 07/14/2021SE |
| K203600 | VersaWrapFTM · Traditional | Alafair Biosciences, Inc. | 03/09/2021SE |
| K192452 | LyograftFTM · Traditional | B. Bruan Surgical, SA | 09/03/2020SE |
| K201000 | Biodesign Staple Line ReinforcementFTM · Traditional | Cook Biotech Incorporated | 07/13/2020SE |
| K201313 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…FTM · Special | Aziyo Biologics, Inc. | 06/15/2020SE |
| K200311 | VersaWrap Tendon ProtectorFTM · Special | Alafair Biosciences, Inc. | 03/06/2020SE |
| K192615 | Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)FTM · Traditional | Synovis Life Technologies, Inc. (Baxter… | 12/17/2019SE |
| K192616 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…FTM · Special | Aziyo Biologics, Inc. | 10/21/2019SE |
| K182493 | Bovine Pericardial Tissue PatchFTM · Traditional | Tisgenx | 06/18/2019SE |
| K183398 | Endoform RestellaFTM · Traditional | Aroa Biosurgery , Ltd. | 04/11/2019SE |
| K183472 | DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio MR ConditionalFTM · Traditional | Synthes (USA) Products, LLC | 03/13/2019SE |
| K182259 | Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalFTM · Traditional | Acell, Inc. | 02/07/2019SE |
| K182255 | CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…FTM · Traditional | Aziyo Biologics, Inc. | 11/15/2018SE |
| K171817 | Biodesign Diaphragmatic Hernia GraftFTM · Traditional | Cook Biotech Incorporated | 03/13/2018SE |
| K173242 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…FTM · Special | Aziyo Biologics, Inc. | 10/25/2017SE |
| K172937 | Colorado Therapeutics Xenograft ImplantFTM · Special | Colorado Therapeutics, LLC | 10/25/2017SE |
| K162934 | Biodesign Parastomal Hernia Repair GraftFTM · Traditional | Cook Biotech Incorporated | 07/10/2017SE |
| K170016 | Biodesign Fistula PlugFTM · Traditional | Cook Biotech Incorporated | 06/21/2017SE |
| K170763 | Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendFTM · Traditional | Acell, Inc. | 06/08/2017SE |
| K162752 | ARTIA Reconstructive Tissue Matrix PerforatedFTM · Traditional | Lifecell Corporation | 02/24/2017SE |
| K162965 | SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionFTM · Traditional | Tei Biosciences, Inc. | 02/16/2017SE |
| K162570 | Miromatrix Biological Mesh TWFTM · Traditional | Miromatrix Medical, Inc. | 02/16/2017SE |
| K162388 | CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)FTM · Traditional | Curaseal, Inc. | 02/03/2017SE |
| K162461 | Endoform Plastics and Reconstructive MatrixFTM · Traditional | Aroa Biosurgery (Formerly Mesynthes Limited) | 12/20/2016SE |
| K162554 | Gentrix Surgical MatrixFTM · Special | Acell, Inc. | 10/21/2016SE |
| K160181 | Colorado Therapeutics Xenograft ImplantFTM · Traditional | Colorado Therapeutics, LLC | 10/20/2016SE |
| K161221 | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugFTM · Special | Cook Biotech Incorporated | 05/26/2016SE |
| K160869 | Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftFTM · Special | Cook Biotech Incorporated | 04/29/2016SE |
| K153633 | Endoform Reconstructive TemplateFTM · Special | Aroa Biosurgery Limited (Formerly Mesynthes… | 03/15/2016SE |
| K152206 | SurgiPure XD Reconstructive Tissue MatrixFTM · Traditional | Tissue Regenix Group Plc | 03/08/2016SE |
| K150668 | Biodesign Enterocutaneous Fistula PlugFTM · Traditional | Cook Biotech Incorprated | 12/09/2015SE |
| K142887 | SIS Inguinal Hernia Repair GraftFTM · Traditional | Cook Biotech Incorprated | 10/01/2015SE |
| K150712 | LTM-Perforated Surgical MeshFTM · Traditional | Lifecell Corporation | 07/02/2015SE |
| K141084 | Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixFTM · Traditional | Acell, Inc. | 06/17/2015SE |
| K142326 | HP Tissue MatrixFTM · Traditional | Lifecell Corporation | 12/23/2014SE |
| K141721 | Bovine Pericardium PatchFTM · Traditional | Collafirm, LLC | 12/22/2014SE |
| K141053 | Ovine Tissue Matrix(Otm)FTM · Traditional | TELA Bio, Inc. | 12/11/2014SE |
| K142070 | Fortiva Porcine Dermis, Tutoplast Porcine DermisFTM · Abbreviated | Rti Surgical, Inc. | 10/27/2014SE |
| K140306 | Cormatrix Protect Ecm EnvelopeFTM · Traditional | Cormatrix Cardiovascular, Inc. | 08/15/2014SE |
| K133306 | Sis Hernia GraftFTM · Traditional | Cook Biotech, Inc. | 07/23/2014SE |
| K140501 | Xenmatrix Surgical GraftFTM · Special | C. R. Bard | 04/28/2014SE |
| K134033 | Miromatrix Biological MeshFTM · Traditional | Miromatrix Medical, Inc. | 03/31/2014SE |
| K132025 | Meso Bilayer Surgical MeshFTM · Traditional | Kensey Nash Corporation Dba Dsm Biomedical | 10/30/2013SE |
| K130547 | Endoform Reconstructive TemplateFTM · Traditional | Mesynthe, Ltd. | 05/31/2013SE |
| K123356 | Fortiva Porcine DermisFTM · Traditional | Rti Biologics, Inc. | 03/05/2013SE |
| K122048 | Collagen Tendon Sheet-DFTM · Traditional | Rotation Medical, Inc. | 01/08/2013SE |
| K120605 | Permacol Surgical ImplantFTM · Traditional | Covidien, LLC | 05/18/2012SE |
| K120019 | Collagen RibbonFTM · Traditional | Wrightmedicaltechnologyinc | 02/23/2012SE |
| K113460 | Synergy Tissue MatrixFTM · Traditional | Synovis Orthopedic & Woundcare | 01/11/2012SE |
| K110581 | Propatch Soft Tissue Repair MatrixFTM · Traditional | Cryolife, Inc. | 01/10/2012SE |
| K112423 | Collagen Tendon SheetFTM · Traditional | Rotation Medical, Inc. | 12/22/2011SE |
| K112786 | Proseries Bioimplants-Proankle/ProcuffFTM · Special | Synovis Orthopedic and Woundcare, Inc. | 10/25/2011SE |
| K111436 | Porcine Surgical Mesh, Porcine Dermal MatrixFTM · Traditional | Brennen Medical, LLC | 10/14/2011SE |
| K111584 | Xylos Macro-Porous Surgical MeshFTM · Traditional | Xylos Corporation | 08/25/2011SE |
| K110402 | Biodesign Nipple Reconstruction CylinderFTM · Traditional | Cook Biotech, Inc. | 06/20/2011SE |
| K103787 | Medeor MatrixFTM · Traditional | Kensey Nash Corp. | 02/07/2011SE |
| K101587 | Propatch Soft Tissue Repair MatrixFTM · Traditional | Cryolife, Inc. | 09/16/2010SE |
| K094061 | Kensey Nash Ecm Surgical PatchFTM · Traditional | Kensey Nash Corporation | 05/18/2010SE |
| K091499 | Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)FTM · Traditional | Kensey Nash Corp. | 10/22/2009SE |
| K091142 | Tutopatch, Tutomesh, Models 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358FTM · Special | Rti Biologics, Inc. | 08/31/2009SE |
| K090880 | Xylos Porous Surgical MeshFTM · Special | Xylos Corporation | 05/27/2009SE |
| K090778 | Mta Protective SheetFTM · Traditional | Xylos Corporation | 04/28/2009SE |
| K083823 | Securian Tissue Reinforcement MatrixFTM · Traditional | Xylos Corporation | 03/18/2009SE |
| K082682 | Surgisis Biodesign Enterocutaneous Fistula PlugFTM · Traditional | Cook Biotech, Inc. | 02/27/2009SE |
| K083898 | SurgimendFTM · Special | Tei Biosciences, Inc. | 02/04/2009SE |
| K083039 | Veritas Collagen Matrix (Dry)FTM · Traditional | Synovis Surgical Innovations | 11/26/2008SE |
| K082176 | Ltm-Bps Surgical MeshFTM · Traditional | Lifecell Corp. | 11/14/2008SE |
| K082687 | Collamend FM ImplantFTM · Traditional | C.R. Bard, Inc. | 10/17/2008SE |
| K081272 | Porcine Surgical Mesh; Dermal MatrixFTM · Traditional | Brennen Medical, LLC | 07/31/2008SE |
| K081882 | Modification to Xylos Surgical MeshFTM · Special | Xylos Corporation | 07/11/2008SE |
| K081538 | Tutopatch, TutomeshFTM · Special | Rti Biologics, Inc. | 06/19/2008SE |
| K080452 | Collagen Tendon WrapFTM · Traditional | Collagen Matrix, Inc. | 05/15/2008SE |
| K073219 | WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…FTM · Traditional | American Medical Systems, Inc. | 04/10/2008SE |
| K073391 | Surgisis Biodesign Tissue GraftFTM · Traditional | Cook Biotech, Inc. | 03/21/2008SE |
| K071986 | Ltm-Rc Surgical MeshFTM · Traditional | Lifecell Corp. | 10/19/2007SE |
| K070405 | Modification to Surgisis SLR Staple Line ReinforcementFTM · Traditional | Cook Biotech, Inc. | 10/17/2007SE |
| K071016 | Depuy Restore Orthobiologic Soft Tissue ImplantFTM · Traditional | DePuy Orthopaedics, Inc. | 09/04/2007SE |
| K071807 | Orthomend Soft Tissue MatrixFTM · Special | Tei Biosciences, Inc. | 08/06/2007SE |
| K062558 | Mesosfol Surgical FilmFTM · Traditional | Biomet Manufacturing Corp | 06/20/2007SE |
| K070560 | LRTM Surgical MeshFTM · Traditional | Lifecell Corp. | 06/11/2007SE |
| K071065 | Orthadapt BioimplantFTM · Special | Pegasus Biologics, Inc. | 05/04/2007SE |
| K070738 | Sis Facial Cylinder, Sis Facial ImplantFTM · Special | Cook Biotech, Inc. | 04/05/2007SE |
| K063556 | Peripatch Endo-SleeveFTM · Traditional | Pm Devices, Inc. | 03/20/2007SE |
| K062915 | Veritas Collagen MatrixFTM · Traditional | Synovis Surgical Innovations | 12/06/2006SE |
| K061892 | Propatch Soft Tissue Repair MatrixFTM · Abbreviated | Cryolife, Inc. | 11/22/2006SE |
| K063178 | Bard Collamend Implant, Models 1175102, 1175103, 1175104, 1175105, 1175106FTM · Traditional | C.R. Bard, Inc. | 11/21/2006SE |
| K062696 | Surgisis, Surgisis EsFTM · Special | Cook Biotech, Inc. | 10/13/2006SE |
| K062729 | Surgisis RVP Recto-Vaginal Fistula PlugFTM · Special | Cook Biotech, Inc. | 10/10/2006SE |
| K062320 | Surgisis Peyronie's Repair Graft, Model SPR-100FTM · Traditional | Cook Biotech, Inc. | 10/02/2006SE |
| K053562 | Zimmer Collagen Repair PatchFTM · Traditional | Tissue Science Laboratories, Plc | 06/23/2006SE |
| K060984 | Xenform Soft Tissue Repair MatrixFTM · Special | Tei Biosciences, Inc. | 05/17/2006SE |
| K060829 | CosmatrixFTM · Abbreviated | Tei Biosciences, Inc. | 05/17/2006SE |
| K060989 | Tissuemend Soft Tissue Repair MatrixFTM · Special | Tei Biosciences, Inc. | 05/15/2006SE |
| K061030 | Bioblanket Surgical MeshFTM · Special | Kensey Nash Corporation | 05/09/2006SE |
| K052322 | Bard Collamend Implant, Models 1175101, 1175102, 1175103, 1175104, 1175105FTM · Traditional | C.R. Bard, Inc. | 04/10/2006SE |
| K053655 | Tendon Wrap Tendon ProtectorFTM · Traditional | Integra LifeSciences Corporation | 02/03/2006SE |
| K051879 | Synthes (USA) Porous Polyethylene ImplantsFTM · Traditional | Synthes (Usa) | 10/05/2005SE |
| K051048 | Surgisis Staple Line Reinforcement IIFTM · Traditional | Cook Biotech, Inc. | 09/23/2005SE |
| K043259 | Bioblanket Surgical MeshFTM · Traditional | Kensey Nash Corp. | 08/15/2005SE |
| K043388 | Pegasus Biologics Orthadapt Surgical MeshFTM · Traditional | Pegasus Biologics, Inc. | 08/05/2005SE |
| K050246 | Sis Dermal Augmentation StrandFTM · Traditional | Cook Biotech, Inc. | 05/19/2005SE |
| K050337 | Sis Fistula PlugFTM · Traditional | Cook Biotech, Inc. | 03/09/2005SE |
| K042809 | CuffpatchFTM · Traditional | Organogenesis, Inc. | 11/02/2004SE |
| K041669 | Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSDFTM · Traditional | Synovis Surgical Innovations | 10/27/2004SE |
| K041923 | BioblanketFTM · Traditional | Kensey Nash Corp. | 09/08/2004SE |
| K040756 | The Trabecular Metal Reconstruction System, Model 10-340-XXXXXFTM · Special | Implex Corp. | 07/14/2004SE |
| K041140 | Acell Ubm Surgical Mesh ML and MlplusFTM · Abbreviated | Acell, Inc. | 07/07/2004SE |
| K040364 | Medpor Craniofacial Implants with Embedded Titanium MeshFTM · Traditional | Porex Surgical, Inc. | 06/30/2004SE |
| K040835 | Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16FTM · Traditional | Pm Devices, Inc. | 06/15/2004SE |
| K040868 | Sepramesh Ip Bioresorbable Barrier - Permanent MeshFTM · Traditional | Genzyme Corp. | 06/04/2004SE |
| K033985 | Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10FTM · Traditional | Pm Devices, Inc. | 06/04/2004SE |
| K040621 | Acell Ubm Surgical MeshFTM · Abbreviated | Acell, Inc. | 04/14/2004SE |
| K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line…FTM · Traditional | Synovis Surgical Innovations | 03/17/2004SE |
| K034039 | Sis Plastic Surgery MatrixFTM · Traditional | Cook Biotech, Inc. | 02/18/2004SE |
| K031969 | Depuy Restore Orthobiologic Soft Tissue ImplantFTM · Traditional | DePuy Orthopaedics, Inc. | 07/28/2003SE |
| K031332 | Bard Pelvisoft Acellular Collagen BiomeshFTM · Abbreviated | C.R. Bard, Inc. | 05/15/2003SE |
| K030782 | Seamguard Bioabsorbable Staple Line Reinforcement MaterialFTM · Traditional | W. L. Gore & Associates, Inc. | 04/21/2003SE |
| K023237 | Xylos Surgical MeshFTM · Traditional | Xylos Corporation | 03/18/2003SE |
| K021056 | PermacolFTM · Traditional | Tissue Science Laboratories, Plc | 10/31/2002SE |
| K021160 | Dermmatrix Surgical MeshFTM · Traditional | Carbon Medical Technologies, Inc. | 06/12/2002SE |
| K021107 | Fortaflex Surgical SlingFTM · Traditional | Organogenesis, Inc. | 05/15/2002SE |
| K021105 | Fortaflex Surgical MeshFTM · Traditional | Organogenesis, Inc. | 05/10/2002SE |
| K020455 | Tissuemend Soft Tissue Repair MatrixFTM · Abbreviated | Tei Biosciences, Inc. | 04/03/2002SE |
| K020049 | Fortaflex Surgical MeshFTM · Traditional | Organogenesis, Inc. | 03/18/2002SE |
| K013625 | PermacolFTM · Traditional | Tissue Science Laboratories, Plc | 01/17/2002SE |
| K011025 | Fortaflex Surgical MeshFTM · Traditional | Organogenesis, Inc. | 08/24/2001SE |
| K011027 | Fortaflex Surgical SlingFTM · Traditional | Organogenesis, Inc. | 05/30/2001SE |
| K001738 | Depuy Restore Orthobiologic Soft Tissue ImplantFTM · Traditional | DePuy Orthopaedics, Inc. | 12/27/2000SE |
| K991296 | TutopatchFTM · Traditional | Tutogen Medical U.S., Inc. | 10/06/2000SE |
| K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and…FTM · Traditional | Bio-Vascular, Inc. | 02/22/2000SE |
| K991567 | Shelhigh No-React Tissue Repair Patch/Uropatch.FTM · Traditional | Shelhigh, Inc. | 07/14/1999SE |
| K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…FTM · Special | Bio-Vascular, Inc. | 10/09/1998SE |
| K982330 | Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantFTM · Traditional | Depuy, Inc. | 09/25/1998SE |
| K980431 | SurgisisFTM · Traditional | Cook Biotech, Inc. | 05/28/1998SE |
| K973379 | Sterile Suprafoil Smooth Nylon Foil SheetsFTM · Traditional | S. Jackson, Inc. | 09/25/1997SE |
| K971048 | Peri-Strips Dry - Staple Line ReinforcementFTM · Traditional | Bio-Vascular, Inc. | 05/09/1997SE |
| K963175 | Glycar Tissue Repair Patch, Bio-Patch, Uro-SlingFTM · Traditional | Glycar, Inc. | 09/23/1996SE |
| K961811 | Peri-Guard PericardiumFTM · Traditional | Bio-Vascular, Inc. | 06/13/1996SE |
| K961810 | Supple Peri-Guard PericardiumFTM · Traditional | Bio-Vascular, Inc. | 06/13/1996SE |
| K940205 | Peri-StripsFTM · Traditional | Bio-Vascular, Inc. | 05/02/1994SE |
| K922308 | Tilghman Titanium Mesh Skeletal Orbit LinerFTM · Traditional | Ti-Mesh, Inc. | 01/12/1993SE |
| K923657 | Supple Peri-GuardFTM · Traditional | Bio-Vascular, Inc. | 12/21/1992SE |
| K915774 | Prolene Polypropylene Mesh Plug W/ Onlay PatchFTM · Traditional | ETHICON, Inc. | 03/02/1992SE |
| K896946 | Coated Novafil, Polybutester, MeshFTM · Traditional | American Cyanamid Co. | 05/07/1990SE |
| K894580 | Gore-Tex Surgical TapeFTM · Traditional | W. L. Gore & Associates, Inc. | 10/10/1989SE |
| K852011 | Nylamid Mesh Pad Full & HalfFTM · Traditional | S. Jackson, Inc. | 06/11/1985SE |
| K851086 | Vicryl (Polyglactin 910/MERSILENE Compoisite MeshFTM · Traditional | ETHICON, Inc. | 05/21/1985SE |
| K844228 | PDS Polydioxanone MeshFTM · Traditional | ETHICON, Inc. | 01/24/1985SE |
| K844225 | Link Acetabular MeshFTM · Traditional | Waldemar Link GmbH & Co. KG | 11/14/1984SE |
| K831725 | Foil in 3 Forms-Non-Sterile SheetsFTM · Traditional | S. Jackson, Inc. | 08/16/1983SE |
| K831727 | Quarter Globe CapsFTM · Traditional | S. Jackson, Inc. | 08/12/1983SE |
| K831723 | Supramid Extra Surgical MeshFTM · Traditional | S. Jackson, Inc. | 08/12/1983SE |
| K831726 | Eye Muscle SleevesFTM · Traditional | S. Jackson, Inc. | 08/11/1983SE |
| K830889 | Dexon 'S' Polyglycolic Acid MeshFTM · Traditional | Davis & Geck, Inc. | 05/09/1983SE |
| K820619 | Mecron(R) Acetabular Nets TMFTM · Traditional | Serrano Intl. | 05/14/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3261-2024 Class II | Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal…Products expire prior to the expiration date printed on the product labeling | Cook Biotech, Inc. | 08/07/2024Open, Classified |
| Z-3260-2024 Class II | Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue…Products expire prior to the expiration date printed on the product labeling | Cook Biotech, Inc. | 08/07/2024Open, Classified |
| Z-3259-2024 Class II | Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue…Products expire prior to the expiration date printed on the product labeling | Cook Biotech, Inc. | 08/07/2024Open, Classified |
| Z-3258-2024 Class II | Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue…Products expire prior to the expiration date printed on the product labeling | Cook Biotech, Inc. | 08/07/2024Open, Classified |
| Z-3257-2024 Class II | Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for…Products expire prior to the expiration date printed on the product labeling | Cook Biotech, Inc. | 08/07/2024Open, Classified |
| Z-3256-2024 Class II | Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for…Products expire prior to the expiration date printed on the product labeling | Cook Biotech, Inc. | 08/07/2024Open, Classified |
| Z-3255-2024 Class II | Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for…Products expire prior to the expiration date printed on the product labeling | Cook Biotech, Inc. | 08/07/2024Open, Classified |
| Z-3254-2024 Class II | Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair…Products expire prior to the expiration date printed on the product labeling | Cook Biotech, Inc. | 08/07/2024Open, Classified |
| Z-3253-2024 Class II | Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair…Products expire prior to the expiration date printed on the product labeling | Cook Biotech, Inc. | 08/07/2024Open, Classified |
| Z-3252-2024 Class II | Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair…Products expire prior to the expiration date printed on the product labeling | Cook Biotech, Inc. | 08/07/2024Open, Classified |
| Z-3251-2024 Class II | Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair…Products expire prior to the expiration date printed on the product labeling | Cook Biotech, Inc. | 08/07/2024Open, Classified |
| Z-3250-2024 Class II | Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair…Products expire prior to the expiration date printed on the product labeling | Cook Biotech, Inc. | 08/07/2024Open, Classified |
| Z-1380-2024 Class II | Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c)…A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in… | Baxter Healthcare Corporation | 02/28/2024Open, Classified |
| Z-1379-2024 Class II | Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d)…A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in… | Baxter Healthcare Corporation | 02/28/2024Open, Classified |
| Z-1378-2024 Class II | Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b)…A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in… | Baxter Healthcare Corporation | 02/28/2024Open, Classified |
| Z-1377-2024 Class II | Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c)…A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in… | Baxter Healthcare Corporation | 02/28/2024Open, Classified |
| Z-0665-2024 Class II | Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO:…Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed… | Baxter Healthcare Corporation | 12/06/2023Open, Classified |
| Z-2085-2023 Class II | TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | TEI Biosciences, Inc. | 05/23/2023Open, Classified |
| Z-2084-2023 Class II | Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | TEI Biosciences, Inc. | 05/23/2023Open, Classified |
| Z-2083-2023 Class II | Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | TEI Biosciences, Inc. | 05/23/2023Open, Classified |
| Z-2076-2023 Class II | SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | TEI Biosciences, Inc. | 05/23/2023Open, Classified |
| Z-2075-2023 Class II | SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | TEI Biosciences, Inc. | 05/23/2023Open, Classified |
| Z-2074-2023 Class II | SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | TEI Biosciences, Inc. | 05/23/2023Open, Classified |
| Z-2073-2023 Class II | SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | TEI Biosciences, Inc. | 05/23/2023Open, Classified |
| Z-2072-2023 Class II | SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | TEI Biosciences, Inc. | 05/23/2023Open, Classified |
| Z-2071-2023 Class II | SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | TEI Biosciences, Inc. | 05/23/2023Open, Classified |
| Z-2070-2023 Class II | SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | TEI Biosciences, Inc. | 05/23/2023Open, Classified |
| Z-2069-2023 Class II | SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm…Possible out of specification endotoxin test results due to issues with in-process and finished goods… | TEI Biosciences, Inc. | 05/23/2023Open, Classified |
| Z-0715-2022 Class II | MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the… | Stryker Leibinger GmbH & Co. KG | 12/29/2021Terminated |
| Z-0807-2021 Class II | VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the…VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions. | Baxter Healthcare Corporation | 12/11/2020Terminated |
| Z-0040-2020 Class II | CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack)…Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device. | Aziyo Biologics | 08/21/2019Terminated |
| Z-0039-2020 Class II | BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium)…Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device. | Aziyo Biologics | 08/21/2019Terminated |
| Z-1033-2019 Class II | Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product…The devices were released from a lot for which one sample failed to meet the company' s tensile strength… | ACell, Inc | 02/14/2019Terminated |
| Z-1032-2019 Class II | Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product…The devices were released from a lot for which one sample failed to meet the company' s tensile strength… | ACell, Inc | 02/14/2019Terminated |
| Z-0435-2019 Class II | OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | AROA Biosurgery, LTD. | 04/06/2018Terminated |
| Z-0434-2019 Class II | OviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | AROA Biosurgery, LTD. | 04/06/2018Terminated |
| Z-0433-2019 Class II | OviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | AROA Biosurgery, LTD. | 04/06/2018Terminated |
| Z-0432-2019 Class II | OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | AROA Biosurgery, LTD. | 04/06/2018Terminated |
| Z-0431-2019 Class II | OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | AROA Biosurgery, LTD. | 04/06/2018Terminated |
| Z-0430-2019 Class II | OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | AROA Biosurgery, LTD. | 04/06/2018Terminated |
| Z-0429-2019 Class II | OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | AROA Biosurgery, LTD. | 04/06/2018Terminated |
| Z-0428-2019 Class II | OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | AROA Biosurgery, LTD. | 04/06/2018Terminated |
| Z-0427-2019 Class II | OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | AROA Biosurgery, LTD. | 04/06/2018Terminated |
| Z-0426-2019 Class II | OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | AROA Biosurgery, LTD. | 04/06/2018Terminated |
| Z-0425-2019 Class II | OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | AROA Biosurgery, LTD. | 04/06/2018Terminated |
| Z-0424-2019 Class II | OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | AROA Biosurgery, LTD. | 04/06/2018Terminated |
| Z-0423-2019 Class II | OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | AROA Biosurgery, LTD. | 04/06/2018Terminated |
| Z-0422-2019 Class II | OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | AROA Biosurgery, LTD. | 04/06/2018Terminated |
| Z-0421-2019 Class II | OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | AROA Biosurgery, LTD. | 04/06/2018Terminated |
| Z-0420-2019 Class II | OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | AROA Biosurgery, LTD. | 04/06/2018Terminated |