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TheraGenesis Meshed Bilayer Wound Matrix

GUNZE LIMITED · Model TG-M4060 · UDI-DI 04967162947191

KGN Prescription

510(k) clearances

185

Adverse events (1 deaths)

Recalls

137

Facilities

Description

TheraGenesis Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine collagen sponge layer and a silicone film layer, and has slits to aid in the drainage of exudate. The collagen sponge layer should be applied to the wound surface. The device also contain a synthetic gauze material to add strength to the silicone film layer. When applied to full-thickness skin defects, TheraGenesis Meshed Bilayer Wound Matrix provides a scaffold for cellular invasion and capillary growth. TheraGenesis Meshed Bilayer Wound Matrix is offered in sheet form of various sizes and is provided terminally sterilized by ethylene oxide, is for single patient use, and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling.

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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Data 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.