FDA Recalls Geistlich Bio-Oss Pen Due to Granule Expulsion Risk
Geistlich Pharma North America is recalling Geistlich Bio-Oss Pen units because granules may be expelled all at once, posing a risk of tissue injury.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, specifically potential tissue irritation or perforation.
Plain-English summary
Geistlich Pharma North America, Inc. is recalling Geistlich Bio-Oss Pen 0.25-1mm 0.25g (Product Number 20115). The product is a natural bone mineral used for filling bone defects in maxillofacial surgery, implantology, and periodontology. The recall involves 1,759 units from lots 81901650 and 82000456, which were distributed nationwide in the US and in Japan.
The recall is due to a defect where it is difficult to expel the granules from the pen. The resistance may suddenly drop, causing the granules to be expelled all at once. This sudden expulsion could cause surrounding tissue injury, particularly when used for sinus lift indications. Potential harms include irritation of the oral mucosa or perforation of the Schneiderian membrane.
Healthcare professionals and patients who have used or possess these specific lots should contact Geistlich Pharma North America, Inc. for further instructions on how to proceed with the recall.
The recalled product
- 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
- Geistlich Pharma North America, Inc.
- Affected units
- 1,759
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lots: 81901650
- 82000456
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Geistlich Pharma North America, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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