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Myriad Matrix™ Restore Restorative Bioscaffold
AROA BIOSURGERY LIMITED · Model SR02LG016S · UDI-DI 09421908222430
2
510(k) clearances
185
Adverse events (1 deaths)
23
Recalls
136
Facilities
Description
Myriad Matrix Restore is an intact extracellular matrix (ECM) derived from ovine (sheep) forestomach tissue. This advanced ECM scaffold is non-reconstituted collagen, thus it retains the innate biological structure and function of the native ECM associated macromolecules including elastin, fibronectin, glycosaminoglycans and laminin.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-19 | Integra LifeSciences Corp. (NeuroSciences) | Increased rate of out-of-specification endotoxin results. |
| 2026-03-19 | Integra LifeSciences Corp. (NeuroSciences) | Increased rate of out-of-specification endotoxin results. |
| 2026-03-19 | Integra LifeSciences Corp. (NeuroSciences) | Increased rate of out-of-specification endotoxin results. |
| 2026-03-19 | Integra LifeSciences Corp. (NeuroSciences) | Increased rate of out-of-specification endotoxin results. |
| 2026-03-19 | Integra LifeSciences Corp. (NeuroSciences) | Increased rate of out-of-specification endotoxin results. |
| 2026-02-10 | Medline Industries, LP | Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic |
| 2023-05-23 | TEI Biosciences, Inc. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| 2023-05-23 | TEI Biosciences, Inc. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| 2023-05-23 | TEI Biosciences, Inc. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| 2023-05-23 | TEI Biosciences, Inc. | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
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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.