# FDA recall Z-2147-2019

> **Geistlich Pharma North America, Inc.** · Class II · device recall initiated 2019-04-12.

## Product

Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 1-2mm 0.5g, For single use only, Part Number 20126 - Product Usage: Augmentation or reconstructive treatment of the alveolar ridge; Filling of infrabony periodontal defects; Filling of defects after root resection, apicoectomy and cystectomy; Filling of extraction sockets to enhance preservation of the alveolar ridge; Elevation of the maxillary sinus floor, etc.

## Reason for recall

When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2147-2019
- **Recalling firm:** Geistlich Pharma North America, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-12
- **Report date:** 2019-08-14
- **Termination date:** 2020-10-21

- **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-2147-2019

## Citation

> AI Analytics. FDA recall Z-2147-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2147-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*