Geistlich Bio-Oss Pen 0.25-1mm 0.25g may expel granules suddenly, causing tissue irritation or perforation. Affected units include specific product numbers from 20115 lots 81901650 and 82000456.
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
Geistlich Bio-Oss Pen 0.25-1mm 0.25g is recalled because it can suddenly expel granules, potentially causing oral tissue irritation or perforation. This risk is highest during sinus lift procedures.
The pen's granules can become difficult to expel, leading to sudden expulsion that may cause irritation of oral tissues or perforation of the Schneiderian membrane. This risk is especially high during sinus lift procedures.
Patients using this pen for maxillofacial surgery, implantology, or periodontology are most at risk. The hazard is particularly concerning during sinus lift procedures.
Check for product number 20115 with lots 81901650 or 82000456. The pen is used for filling bone defects in maxillofacial surgery, implantology, and periodontology.
Verify the product number (20115) and lot numbers (81901656, 82000456) to confirm if your pen is affected.
The recall indicates a potential risk of sudden granule expulsion, which could cause tissue irritation or perforation, so it is not recommended for use without checking the recall.
The recall does not specify a remedy, so check the product details to confirm if your pen is affected and contact the manufacturer for further guidance.
The recall mentions a risk of tissue irritation or perforation, but it states this is unlikely and occurs during specific procedures like sinus lifts.
We’ve drafted a message you can send Geistlich to request your refund or repair — edit it as you like.
Subject: Recall Z-0490-2021 — Geistlich Geistlich Hello, I own a Geistlich that is covered by recall Z-0490-2021 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.
