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Endoform Surface

AROA BIOSURGERY LIMITED · Model SR03LG1020 · UDI-DI 09421904065673

FTM KGN Prescription

510(k) clearances

11,594

Adverse events (47 deaths)

Recalls

Facilities

Description

Endoform Surface is intended for applications in plastic and reconstructive surgery or to cover, protect, and provide a moist wound environment. The device may be fixed, via sutures, staples, or tacks to the surrounding tissue, if desired.

Recalls

Date	Firm	Reason
2024-08-07	Cook Biotech, Inc.	Products expire prior to the expiration date printed on the product labeling
2024-08-07	Cook Biotech, Inc.	Products expire prior to the expiration date printed on the product labeling
2024-08-07	Cook Biotech, Inc.	Products expire prior to the expiration date printed on the product labeling
2024-08-07	Cook Biotech, Inc.	Products expire prior to the expiration date printed on the product labeling
2024-08-07	Cook Biotech, Inc.	Products expire prior to the expiration date printed on the product labeling
2024-08-07	Cook Biotech, Inc.	Products expire prior to the expiration date printed on the product labeling
2024-08-07	Cook Biotech, Inc.	Products expire prior to the expiration date printed on the product labeling
2024-08-07	Cook Biotech, Inc.	Products expire prior to the expiration date printed on the product labeling
2024-08-07	Cook Biotech, Inc.	Products expire prior to the expiration date printed on the product labeling
2024-08-07	Cook Biotech, Inc.	Products expire prior to the expiration date printed on the product labeling

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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.