Use caution Medical device recall · FDA · Published October 19, 2020

Geistlich Bio-Oss Pen 1-2mm 0.5g: Risk of sudden granule expulsion causing tissue damage

Geistlich Pharma recalls Bio-Oss Pen 1-2mm 0.5g due to potential sudden expulsion of granules during use, risking oral tissue damage. Affected units include specific product numbers for maxillofacial surgery.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0492-2021Medical device Geistlich ›

Use caution until it’s fixed

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

Take action

Contact the company

Recalling firmGeistlich Pharma North America, Inc.202 Carnegie Ctr Ste 103 · Princeton, NJ 08540-6239

✎ GovInfoNow plain-language explainer

Geist: Geistlich Bio-Oss Pen 1-2mm 0.5g is recalled because it can suddenly expel granules during use, potentially causing tissue damage like irritation or perforation. This risk is highest for patients using it for sinus lifts or similar procedures. Read more at govinfonow.com/recall/64075-geistlich-bio-oss-pen-1-2mm-0-5g-risk-of.

Source Summary by GovInfoNow · govinfonow.com/recall/64075-geistlich-bio-oss-pen-1-2mm-0-5g-risk-of · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0492-2021

Cite this page

“Geistlich Bio-Oss Pen 1-2mm 0.5g: Risk of sudden granule expulsion causing tissue damage.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64075-geistlich-bio-oss-pen-1-2mm-0-5g-risk-of. Based on FDA recall #Z-0492-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0492-2021%22&limit=1).

The FDA announced on 2020-10-19 that Geistlich Pharma North America, Inc. is recalling Geistlich Bio-Oss Pen 1-2mm 0.5g devices due to a risk of patient harm. The agency said the granules may be expelled all at once if resistance drops suddenly.

How to tell if you have it

Brand: Geistlich
Product: Geistlich Bio-Oss Pen 1-2mm 0.5g
Product Number: 20126
Lots: 81901651, 82000466
Units affected: 537

The hazard

The FDA said difficult expulsion of the granules could cause them to be expelled all at once. This poses a risk for patient harm, including irritation of the oral mucosa or perforation of the Schneiderian membrane.

Context

GovInfoNow's records show Geistlich Pharma North America, Inc. has one other recall on record since 2019-04-12. Other recent recalls of similar products include Olympus Single Use Sphincterotome V Recall (2026-01-07), Olympus Single Use Biopsy Valve Recall (2026-01-29) and Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (2026-03-03).

How to tell if you have this one

Check for product numbers 20126 with lots 81901651 or 82000466. The pen is used for filling bone defects in maxillofacial surgery, implantology, and periodontology.

Brand
Geistlich
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US Nationwide distribution and the country of Japan.

Recall number	Product, codes & lots	Quantity
Z-0490-2021	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; Lots: 81901650, 82000456	1759 units
Z-0491-2021	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; Lots: 81901649, 82000457, 82000633	2097 units
Z-0492-2021	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; Lots: 81901651,82000466	537 units

Based on the official FDA remedy

What to do — step by step

Check Product Number
Verify the product number is 20126 with lots 81901651 or 82000466.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide distribution and the country of Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 9 months after the firm started it.

Oct 19, 2020Firm started the recall
Nov 25, 2020FDA classified it Class II
Dec 2, 2020Published in FDA’s Enforcement Report
Jul 13, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/64075-geistlich-bio-oss-pen-1-2mm-0-5g-risk-of">Geistlich Bio-Oss Pen 1-2mm 0.5g: Risk of sudden granule expulsion causing tissue damage (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0492-2021 (October 19, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0492-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.