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TELAMax 1S

TELA BIO, INC. · Model F10069-1822 · UDI-DI 10856072005088

FTM Prescription

510(k) clearances

11,622

Adverse events (48 deaths)

Recalls

Facilities

Description

TELAMax 1S is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene. The device consists of two sides: a textured and smooth side. The textured side of the device, indicated with blue polypropylene, provides a surface conducive for tissue ingrowth. The smooth side of the device, containing clear polypropylene, provides a surface designed to minimize tissue attachment. TELAMax 1S will incorporate into the recipient tissue with associated cellular and microvascular ingrowth. TELAMax 1S is provided in various shapes and sizes to suit surgeon preference and the complexity of the soft tissue repair. The device may be trimmed to a desired shape to further accommodate an individual patient's requirements.

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.