Devices

PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant

Model / Serial
Lot Number 100076901, 100077013, 100077249, 100077250, 100078691, 100079054, 100079213, 100079597, 100079954, 100080082, 100081008, 100081401, 100081573, 100081916, 100082248, 100082468, 100082695, 100082729, 100083126, 100083785, 100083934
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 PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implant used to treat vocal fold insufficiency.
Manufacturer
Merz North America, Inc.
1 Event
- Recall of PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant

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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