medical Class II Updated 2020-12-02

Geistlich Pharma North America, Inc. recalls Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natura

Recalled 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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lots: 81901650, 82000456
View official government recall

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