Reported Dec 2, 2020 · Terminated
Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial…
Geistlich Pharma North America, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Geistlich Pharma North America, Inc. · 202 Carnegie Ctr Ste 103 · Princeton, NJ · 08540-6239
Is this the product you have?
- Geistlich Bio-Oss Pen 0.25-1mm 0.25g -
- Product Usagenatural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology
- Product Number20115
- Lot codes and dates
- Lots
8190165082000456
- Lots
- Amount recalled
- 1759 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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