Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone Recalled by Geistlich Pharma North America, Inc. Due to Difficult to expel Geistlich Bio-Oss granules from the...

Date: October 19, 2020
Company: Geistlich Pharma North America, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Geistlich Pharma North America, Inc. directly.

Affected Products

Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20116

Quantity: 2097 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Geistlich Pharma North America, Inc.

Geistlich Pharma North America, Inc. has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report