FDA-Device2020-12-02Class II

Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20115

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
1759 units
Manufactured in
202 Carnegie Ctr Ste 103, N/A, Princeton, NJ, United States
Products
Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20115

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0490-2021

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief