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Geistlich Pharma North America, Inc. recalls Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial
Recalled December 2, 2020 · FDA recall Z-0490-2021 · Geistlich Pharma North America
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 · FDA Class II
Units
1759 units
Sold at
Worldwide distribution - US Nationwide distribution and the country of Japan.
Description
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
Product
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
Manufacturer(s)
Geistlich Pharma North America, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →