Renú Voice

CYTOPHIL, INC. · Model 08-015-04-V04 · UDI-DI 00856509002294

MIX Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Renú Calcium Hydroxylapatite Vocal Fold Implant is a sterile, semi-solid, cohesive implant indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue-bulking agent.

Recalls

Date	Firm	Reason
2015-10-26	Merz North America, Inc.	The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.

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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.