# FDA recall Z-0490-2021

> **Geistlich Pharma North America, Inc.** · Class II · device recall initiated 2020-10-19.

## 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 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

## Distribution

Worldwide distribution - US Nationwide distribution and the country of Japan.

## Key facts

- **Recall number:** Z-0490-2021
- **Recalling firm:** Geistlich Pharma North America, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-19
- **Report date:** 2020-12-02
- **Termination date:** 2021-07-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0490-2021

## Citation

> AI Analytics. FDA recall Z-0490-2021. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-0490-2021. Source: US FDA. Licensed CC0.

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