Geistlich Bio-Oss Pen 0.25-1mm recall
Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and…
Why was Geistlich Bio-Oss Pen 0.25-1mm 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots: 81901650, 82000456
- 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…
- Recalling firm
- Geistlich Pharma North America, Inc.
- Quantity
- 1759 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the country of Japan.
- Recall date
- December 2, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)