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
Reported: December 2, 2020 Initiated: October 19, 2020 #Z-0492-2021
Product Description
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
Reason for Recall
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
Details
- Recalling Firm
- Geistlich Pharma North America, Inc.
- Units Affected
- 537 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the country of Japan.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Geistlich Pharma North America, Inc.. Units affected: 537 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 2, 2020. Severity: Moderate. Recall number: Z-0492-2021.
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