Device product
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
Z-0492-2021
Product summary
- Event
- Event 86628
- Status
- Terminated
- Classification
- Class II
- Quantity
- 537 units
- Official record key
device-enforcement:Z-0492-2021
Official wording
Reason: 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
Code information: Lots: 81901651,82000466
Distribution pattern: Worldwide distribution - US Nationwide distribution and the country of Japan.
Derived failure modes
-
Unknown
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