Mesh, Surgical, Polymeric
General, Plastic Surgery · 21 CFR 878.3300
Recent MDR events
170,120 adverse event reports on file
- ProGripJul 31, 2026InjurySofradim Production Sas9615742-2026-00739
- 3DMaxJul 31, 2026InjuryDavol Inc., Sub. C.r. Bard, Inc. -12136431213643-2026-00990
- Ventralight ST MeshJul 31, 2026InjuryDavol Inc., Sub. C.r. Bard, Inc. -12136431213643-2026-00991
- Bard Soft MeshJul 31, 2026InjuryDavol Inc., Sub. C.r. Bard, Inc. -12136431213643-2026-00992
- Prolene MeshJul 31, 2026InjuryEthicon Inc.2210968-2026-07664
- VersatexJul 31, 2026InjurySofradim Production Sas9615742-2026-00740
- Bard Mesh Pre-ShapedJul 31, 2026InjuryDavol Inc., Sub. C.r. Bard, Inc. -12136431213643-2026-00994
- ParietexJul 31, 2026InjurySofradim Production Sas9615742-2026-00741
- 3DMaxJul 31, 2026InjuryDavol Inc., Sub. C.r. Bard, Inc. -12136431213643-2026-00998
- Bard Flat MeshJul 31, 2026InjuryDavol Inc., Sub. C.r. Bard, Inc. -12136431213643-2026-00997
Event type breakdown
Recalls
73 recall events for this product code
- Chamberlain Technologies LLCOpen, ClassifiedJun 17, 2025
SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model/Catalog Number: T3030
Potential presence of residual adhesive material on the mesh surface.
Z-1983-2025 · View FDA record ↗ - Chamberlain Technologies LLCOpen, ClassifiedJun 17, 2025
SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415
Potential presence of residual adhesive material on the mesh surface.
Z-1984-2025 · View FDA record ↗ - Chamberlain Technologies LLCOpen, ClassifiedJun 17, 2025
SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
Potential presence of residual adhesive material on the mesh surface.
Z-1985-2025 · View FDA record ↗ - Chamberlain Technologies LLCOpen, ClassifiedJun 17, 2025
SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415
Potential presence of residual adhesive material on the mesh surface.
Z-1986-2025 · View FDA record ↗ - W.L. Gore & Associates, Inc.Open, ClassifiedAug 6, 2024
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
Z-2513-2024 · View FDA record ↗ - Davol, Inc.Open, ClassifiedJul 27, 2023
Ventralight ST 4" x 6" Ellipse with Echo PS
Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Z-2241-2023 · View FDA record ↗ - Davol, Inc.Open, ClassifiedJul 27, 2023
Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for th
Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Z-2242-2023 · View FDA record ↗ - Davol, Inc.Open, ClassifiedJul 27, 2023
Ventralight ST w Echo PS 4.5" Circle
Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Z-2243-2023 · View FDA record ↗ - Davol, Inc.Open, ClassifiedJul 27, 2023
Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the
Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Z-2244-2023 · View FDA record ↗ - Covidien, LPOpen, ClassifiedFeb 27, 2023
Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe-
Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions, erosion/migration, pain, fistula, hernia (recurrence), and failure of implant
Z-1183-2023 · View FDA record ↗
Registered firms
511 firms currently registered for this product code
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Boylston Surgical Llc
Osterville, MA, US
Synergy Health Sterilisation Uk Ltd
Daventry Northamptonshire, GB
Grant Technologies Llc
Lake Zurich, IL, US
Sterigenics U.s., Llc
Rockaway, NJ, US
Synergy Health Ede Bv
Venlo Limburg, NL
Davol Inc., Sub. C.r. Bard, Inc.
Warwick, RI, US
Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi
Istanbul, TR
Aroa Biosurgery Ltd
Airport Oaks Auckland, NZ
Johnson & Johnson Medical Gmbh
NORDERSTEDT Schleswig-Holstein, DE
Medtronic, Inc.
Mounds View, MN, US
Cardimed Asia Medikal Sanayi Ve Ticaret Ltd Sti
Maltepe Istanbul, TR
Medtronic Distribution Center
Memphis, TN, US
Medtronic, Inc.
Minneapolis, MN, US
Steriservices
Bernay Eure, FR
Dylan Lucas International Inc
Vaughan Ontario, CA
Burak Global Ic Ve Dis Tic Ltd Sti
Kocasinan Kayseri, TR
Synthes (usa) Products Llc
West Chester, PA, US
Bard Shannon Limited
Humacao, PR, US
Artelon
ATL, GA, US
Rose Gmbh Fuer Medizintechnik
Trier Rhineland-Palatinate, DE
510(k) clearances
336 clearances for this product code
- Sofradim ProductionMay 21, 2026
K253956 · ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)
- Medtronic - Sofradim ProductionOct 24, 2025
K253125 · Parietene Flat Sheet Mesh
- Davol Inc., Subsidiary of C. R. Bard, Inc.Jul 24, 2025
K251955 · Onflex Mesh
- Davol, Inc.Jun 12, 2025
K251557 · Bard® Mesh; Bard® Mesh Pre-Shaped
- Sofradim ProductionApr 23, 2025
K250869 · Parietene Macroporous Mesh (PPM5050 )
- Davol, Inc.Apr 9, 2025
K250098 · Bard Soft Mesh; Bard Soft Mesh Pre-Shaped
- Sofradim ProductionJan 17, 2025
K243315 · ProGrip Self-Gripping Polypropylene Mesh
- Davol Inc., Subsidiary of C. R. Bard, Inc.Jun 14, 2024
K241250 · 3DMax Light Mesh