FDA-Device2020-12-02Class II
Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20116
Geistlich Pharma North America, Inc.
Hazard
Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly in use for the sinus lift indication and while unlikely, could pose a risk for patient harm, including irritation of the oral mucosa or even a perforation of the Schneiderian membrane
Sold states
Worldwide distribution - US Nationwide distribution and the country of Japan.
Affected count
2097 units
Manufactured in
202 Carnegie Ctr Ste 103, N/A, Princeton, NJ, United States
Products
Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20116
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0491-2021Don't want to check this manually?
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