Geistlich Bio-Oss Pen Recall: Visible Green Plastic During Unscrewing
Geistlich Pharma North America recalls Bio-Oss Pen (Part 20126) due to visible green plastic during unscrewing. Affected lots: 81700464, 81700811, 81800292, 81800866. No remedy stated in recall.
Lower-risk recall
When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
Contact the company
What happened, in plain English
Geistlich Bio-Oss Pen (Part 20126) is recalled because a visible piece of green plastic can be seen on the outer barrel when unscrewing the green cap. This could cause injury during dental procedures if the plastic piece is dislodged. Read more at govinfonow.com/recall/68343-geistlich-bio-oss-pen-recall-visible-green-plastic-during-unscrewing.
Source Summary by GovInfoNow · govinfonow.com/recall/68343-geistlich-bio-oss-pen-recall-visible-green-plastic-during-unscrewing · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2147-2019
Cite this page
“Geistlich Bio-Oss Pen Recall: Visible Green Plastic During Unscrewing.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68343-geistlich-bio-oss-pen-recall-visible-green-plastic-during-unscrewing. Based on FDA recall #Z-2147-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2147-2019%22&limit=1).
Why it’s dangerous
The hazard occurs when unscrewing the green cap, where a visible piece of green plastic may appear on the outer barrel. This plastic piece could potentially become dislodged during dental procedures, causing injury to the patient or clinician.
Who’s affected
Dentists and dental clinics using Geistlich Bio-Oss Pen (Part 20126) for dental procedures are affected. Patients receiving the product may be at risk if plastic pieces are dislodged during treatment.
How to tell if you have this one
Check for the product name 'Geistlich Bio-Oss Pen', Part Number 20126, and affected lots: 81700464, 81700811, 81800292, 81800866. The product is used for dental procedures like alveolar ridge augmentation.
- Brand
Geist: 20126- Category
Medical device
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
US Nationwide distribution.
| Recall number | Product, codes & lots |
|---|---|
| Z-2145-2019 | Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number 20115 - 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.; Lots: 81600759, 81700193, 81700810, 81701004, 81800288, 81800862, 81900056. |
| Z-2146-2019 | 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.; Lots: 81600760, 81700194, 81700829, 81800289, 81800863. |
| Z-2147-2019 | 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.; Lots: 81700464, 81700811, 81800292, 81800866. |
What to do — step by step
Check for Visible Plastic
Inspect the outer barrel for a visible piece of green plastic when unscrewing the green cap.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-2147-2019 (April 12, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2147-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.