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Restella

AROA BIOSURGERY LIMITED · Model R20243-1122P · UDI-DI 09421904065994

FTM FTL Prescription

510(k) clearances

11,622

Adverse events (48 deaths)

Recalls

Facilities

Description

Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.

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.