Geistlich Bio-Oss Pen 1-2mm 0 — Class II medical device recall Z-0492-2021
Terminated recall by Geistlich Pharma North America, Inc., reported 2020-12-02, distributed nationwide. Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules m
| Recall number | Z-0492-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Geistlich Pharma North America, Inc., Princeton, NJ, United States |
| Recall initiated | 2020-10-19 |
| Classified | 2020-11-25 |
| Reported by FDA | 2020-12-02 |
| Terminated | 2021-07-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
| Quantity | 537 units |
| Lot numbers | 81901651, 82000466 |
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
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0492-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.