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Prolaryn Plus
MERZ NORTH AMERICA, INC. · Model 1.0 cc · UDI-DI 00810235030853
KHJ
Prescription
1
510(k) clearances
23
Adverse events
2
Recalls
25
Facilities
Description
Prolaryn® Plus is a sterile, latex-free, injectable implant used to treat vocal fold insufficiency, paralysis, and atrophy by augmenting (bulking) damaged vocal folds to improve voice production. It consists of synthetic calcium hydroxylapatite microspheres suspended in a water-based gel, providing long-term structural support, with effects lasting up to one year.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-22 | Cook Biotech, Inc. | Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. |
| 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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