Devices

PROLARYN Injectable Implant 1.0 cc Gel

Model / Serial
Lot Number 100079214, 100077099, 100077251, 100077252, 100077253, 100078692, 100079598, 100080204, 100081409, 100081577, 100082304, 100082438, 100083371, 100083875, 100083932
Product Classification
Ear, Nose, and Throat Devices
Device Class
2
Implanted device?
Yes
Distribution
Distributed US (nationwide) including the Virgin Islands and South Africa.
Product Description
PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.
Manufacturer
Merz North America, Inc.
1 Event
- Recall of PROLARYN Injectable Implant 1.0 cc Gel

Manufacturer

Merz North America, Inc.

Manufacturer Address
Merz North America, Inc., 6501 Six Forks Rd, Raleigh NC 27615-6515
Manufacturer Parent Company (2017)
Merz Holding Gmbh & Co. Kg
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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