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.
What this means for you
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, fitting the 'High' severity criteria for potential tissue injury without confirmed cases.
Plain-English summary
Geistlich Pharma North America, Inc. is recalling Geistlich Bio-Oss Pen 0.25-1mm 0.5g (Product Number 20116). The product is a natural bone mineral used for filling bone defects in maxillofacial surgery, implantology, and periodontology. The recall involves 2,097 units distributed in the United States and Japan.
The recall is being conducted because the granules are difficult to expel from the pen. Resistance may suddenly drop, causing the granules to be expelled all at once. This sudden expulsion could cause surrounding tissue injury, including irritation of the oral mucosa or perforation of the Schneiderian membrane, particularly during sinus lift procedures.
The affected lots are 81901649, 82000457, and 82000633. Healthcare providers and patients should check their inventory and product packaging for these lot numbers. If you have used this product, contact your healthcare provider for guidance.
The recalled product
- Product
- 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
- Manufacturer
- Geistlich Pharma North America, Inc.
- Affected units
- 2,097
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 (3)
- Lots: 81901649
- 82000457
- 82000633
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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