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 Recalled by Geistlich Pharma North America, Inc. Due to When unscrewing the green cap from the pen,...

Date: April 12, 2019
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, Sterile cancellous granules in an applicator, 0.25-1.mm 0.5g, For single use only, Part Number 20116 - 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.

Quantity: 244,268 total

Why Was This Recalled?

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

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