FDA Device recall Z-0490-2021
Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantolo…
- FDA Device
- Class II
- terminated
- Published 2020-12-02
On 2020-12-02 the FDA classified a Class II recall of Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantolo… by Geistlich Pharma North America, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0490-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-19 |
| Published | 2020-12-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Geistlich Pharma North America |
| Distribution | US |
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 periodontology. Product Number: 20115
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
Identifiers
| code_info | Lots: 81901650, 82000456 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0490-2021%22
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