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ArtiFascia®
NURAMI MEDICAL LTD · Model 3cm X 4cm (1.18" X 1.57") · UDI-DI 07290019685005
GXQ
Prescription
1
510(k) clearances
1,404
Adverse events (36 deaths)
23
Recalls
42
Facilities
Description
ArtiFascia® is an absorbable dural repair graft for the repair of cranial dural defects. ArtiFascia® is a highly flexible, easy to handle, non-friable soft matrix composed of synthetic non-woven fibers and a non-porous film. ArtiFascia® readily conforms to the surface of the wound area and is applied to the dural defect by using sutures.
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 clinically with signs |
| 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 the event a surgeon |
| 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 the event a surgeon |
| 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 the event a surgeon |
| 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 the event a surgeon |
| 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 the event a surgeon |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.