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.
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
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.
The pen can have difficulty expelling granules, which may suddenly be expelled all at once. This could cause irritation of the oral mucosa or even perforation of the Schneiderian membrane, especially during sinus lift procedures.
Patients using the Geistlich Bio-Oss Pen 1-2mm 0.5g for maxillofacial surgery, implantology, or periodontology are most at risk. The hazard is particularly concerning during sinus lift procedures.
Check for product numbers 20126 with lots 81901651 or 82000466. The pen is used for filling bone defects in maxillofacial surgery, implantology, and periodontology.
Verify the product number is 20126 with lots 81901651 or 82000466.
The pen can suddenly expel granules all at once, potentially causing oral tissue damage like irritation or perforation, especially during sinus lift procedures.
The recall record does not specify a remedy.
It is used for filling bone defects in maxillofacial surgery, implantology, and periodontology.
We’ve drafted a message you can send Geistlich to request your refund or repair — edit it as you like.
Subject: Recall Z-0492-2021 — Geistlich Geistlich Hello, I own a Geistlich that is covered by recall Z-0492-2021 from Geistlich. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
