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Dura Substitute
FDA product code GXQ · Class 2 · Neurology
241
Registered devices
1,418
Adverse events
23
Recalls
43
510(k) clearances
Devices with this code
DURAFORM — Cerenovus, Inc.DURA-GUARD Dural Repair Patch — SYNOVIS LIFE TECHNOLOGIES, INC.DuraMatrix — COLLAGEN MATRIX, INC.Biodesign — COOK BIOTECH INCORPORATEDDURASIS — COOK BIOTECH INCORPORATEDDURAFORM — Cerenovus, Inc.Welch Allyn, Inc. — WELCH ALLYN, INC.SyntheCel — Synthes GmbHDuraMatrix-Onlay Conform — COLLAGEN MATRIX, INC.DuraMend-Onlay™ — COLLAGEN MATRIX, INC.SyntheCel — Synthes GmbHIntegra® DuraFlex® — Integra Lifesciences CorporationDURAFORM — Cerenovus, Inc.DURAFORM — Cerenovus, Inc.SyntheCel — Synthes GmbHWelch Allyn, Inc. — WELCH ALLYN, INC.DuraGen® — Integra Lifesciences CorporationDuraGen® Plus — Integra Lifesciences CorporationIntegra® Bovine Pericardium Dural Graft — Integra Lifesciences CorporationDuraGen® — Integra Lifesciences CorporationDurepair® — MEDTRONIC PS MEDICAL, INC.DuraMatrix Onlay — COLLAGEN MATRIX, INC.Biodesign — COOK BIOTECH INCORPORATEDDURAFORM — NATUS MEDICAL INCORPORATED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-22 | Cook Biotech, Inc. | Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. |
| 2024-09-26 | Integra LifeSciences Corp. | Out of specification endotoxin levels. |
| 2023-06-13 | Medtronic Neurosurgery | Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and finished goods endotoxin testing, which may present cl |
| 2021-12-13 | Collagen Matrix, Inc. | Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery |
| 2021-12-13 | Collagen Matrix, Inc. | Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery |
| 2015-12-08 | Synthes (USA) Products LLC | It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in |
| 2015-12-08 | Synthes (USA) Products LLC | It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in |
| 2015-12-08 | Synthes (USA) Products LLC | It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in |
| 2015-12-08 | Synthes (USA) Products LLC | It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in |
| 2015-12-08 | Synthes (USA) Products LLC | It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in |
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