FDAOctober 19, 2020device

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 recall recorded by the U.S. Food & Drug Administration.

The 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

What to do

FDA enforcement status: Terminated

Brands named

geistlich pharma north americageistlichgeistlich pharma

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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