Mesh, Surgical
General, Plastic Surgery · 21 CFR 878.3300
Recent MDR events
11,595 adverse event reports on file
- Surgimend matrix - unspecifiedJul 31, 2026InjuryTei Biosciences Inc3004170064-2026-00006
- Surgimend matrix - unspecifiedJul 31, 2026InjuryTei Biosciences Inc3004170064-2026-00008
- Surgimend matrix - unspecifiedJul 31, 2026InjuryTei Biosciences Inc3004170064-2026-00010
- Surgimend matrix - unspecifiedJul 31, 2026InjuryTei Biosciences Inc3004170064-2026-00007
- Surgimend matrix - unspecifiedJul 31, 2026InjuryTei Biosciences Inc3004170064-2026-00009
- Surgimend matrix - unspecifiedJul 31, 2026DeathTei Biosciences Inc3004170064-2026-00023
- Surgimend matrix - unspecifiedJul 31, 2026InjuryTei Biosciences Inc3004170064-2026-00017
- Surgimend matrix - unspecifiedJul 31, 2026InjuryTei Biosciences Inc3004170064-2026-00015
- Surgimend matrix - unspecifiedJul 31, 2026InjuryTei Biosciences Inc3004170064-2026-00013
- Surgimend matrix - unspecifiedJul 31, 2026InjuryTei Biosciences Inc3004170064-2026-00016
Event type breakdown
Recalls
76 recall events for this product code
- TEI Biosciences, Inc.Open, ClassifiedSep 30, 2024
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 1
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Z-2069-2023 · View FDA record ↗ - TEI Biosciences, Inc.Open, ClassifiedSep 30, 2024
SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval,
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Z-2070-2023 · View FDA record ↗ - TEI Biosciences, Inc.Open, ClassifiedSep 30, 2024
SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Z-2071-2023 · View FDA record ↗ - TEI Biosciences, Inc.Open, ClassifiedSep 30, 2024
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, 20x25
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Z-2072-2023 · View FDA record ↗ - TEI Biosciences, Inc.Open, ClassifiedSep 30, 2024
SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Z-2073-2023 · View FDA record ↗ - TEI Biosciences, Inc.Open, ClassifiedSep 30, 2024
SurgiMend 3.0; 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, 20x25
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Z-2074-2023 · View FDA record ↗ - TEI Biosciences, Inc.Open, ClassifiedSep 30, 2024
SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Z-2075-2023 · View FDA record ↗ - TEI Biosciences, Inc.Open, ClassifiedSep 30, 2024
SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Z-2076-2023 · View FDA record ↗ - TEI Biosciences, Inc.Open, ClassifiedSep 30, 2024
Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Z-2083-2023 · View FDA record ↗ - TEI Biosciences, Inc.Open, ClassifiedSep 30, 2024
Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Z-2084-2023 · View FDA record ↗
Registered firms
251 firms currently registered for this product code
Baxter Healthcare Corporation
ROUND LAKE, IL, US
Amcor Flexibles, Commerce
COMMERCE, CA, US
Cook Incorporated
ELLETTSVILLE, IN, US
Medtronic Neurosurgery
Fort Worth, TX, US
Aroa Biosurgery Ltd
Airport Oaks Auckland, NZ
Sterigenics Radiation Technologies, Llc
San Diego, CA, US
Sterigenics Radiation Technologies In, Inc
Columbia City, IN, US
Tisgenx, Inc.
Irvine, CA, US
Isomedix Operations, Inc.
Minneapolis, MN, US
Acell, Inc.
Columbia, MD, US
Bard Shannon Limited
Humacao, PR, US
Synthes (usa) Products Llc
West Chester, PA, US
Lynx Medical Nj
Franklin, NJ, US
Lifecell Corp.
BRANCHBURG, NJ, US
Synergy Health Ast, Llc
Saxonburg, PA, US
Isomedix Operations Inc.
Chester, NY, US
Sterigenics Belgium Fleurus Sa
Fleurus Hainaut, BE
Pfm Medical Titanium Gmbh
NUREMBERG Bavaria, DE
Tutogen Medical Gmbh
Neunkirchen am Brand Bavaria, DE
Lemaitre Vascular Inc.
Billerica, MA, US
Depuy Orthopaedics
BRIDGEWATER, MA, US
Sofradim Production
TREVOUX Auvergne-Rhone-Alpes, FR
510(k) clearances
163 clearances for this product code
- Aroa Biosurgery , Ltd.Jun 3, 2025
K250598 · Endoform Reconstructive Template - PLGA
- TELA Bio, Inc.Dec 19, 2024
K243595 · OviTex PRS (Long-Term Resorbable)
- Elutia, Inc.Jun 14, 2024
K233991 · CanGaroo RM Antibacterial Envelope
- TELA Bio, Inc.May 22, 2024
K241126 · OviTex PRS
- Synovis Life Technologies, Inc.Apr 7, 2023
K223052 · Peri-Guard and Supple Peri-Guard
- Tela BioMar 21, 2023
K214070 · OviTex PRS (Long Term Resorbable)
- Alafair Biosciences, Inc.Oct 29, 2021
K213163 · VersaWrap
- Synovis Life Technologies. Inc. (A Subsidiary of BaxterOct 27, 2021
K213125 · PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology