FDAFDA · Food and drugs·Recall number Z-0492-2021
Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20126
Published December 2, 2020 · Recall initiated: October 19, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Geistlich Pharma North America, Inc.
- Distributor
- Worldwide distribution - US Nationwide distribution and the country of Japan.
- Lot
- Lots: 81901651,82000466
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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