Geistlich Pharma North America, Inc. recalls Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial…

Recall date

October 19, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0491-2021

FDA classification

Class II

Brand / firm

Geistlich Pharma North America, Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution and the country of Japan.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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