Geistlich Bio-Oss Pen 0.25-1mm 0.5g may expel granules suddenly during sinus lift procedures, risking tissue damage. Affected units include specific product numbers from 81901649 to 82000633.
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 0.5g is recalled because it can suddenly expel granules during sinus lift procedures, potentially causing tissue damage or perforation. This risk is most concerning for dental surgeons using the product for bone defect repairs.
The pen's granules can become difficult to expel, leading to sudden expulsion that may cause tissue damage. This risk is highest during sinus lift procedures where the granules could perforate the Schneiderian membrane.
Dental surgeons and medical professionals using Geistlich Bio-Oss Pen for maxillofacial surgery, implantology, or periodontology are most at risk. Patients undergoing sinus lift procedures with this product could experience tissue irritation or perforation.
Check for product numbers 81901649, 82000457, or 82000633 on the Geistlich Bio-Oss Pen 0.25-1mm 0.5g packaging. The product is used for filling bone defects in dental procedures.
Look for product numbers 81901649, 82000457, or 82000633 on the pen's packaging.
The product is not safe for use in sinus lift procedures due to the risk of sudden granule expulsion. Dental professionals should check the product number and follow the recall instructions.
The recall does not specify a remedy, so contact Geistlich Pharma North America, Inc. for guidance on next steps.
Yes, the product could cause tissue damage or perforation of the Schneiderian membrane during sinus lift procedures, though this is unlikely.
We’ve drafted a message you can send Geistlich to request your refund or repair — edit it as you like.
Subject: Recall Z-0491-2021 — Geistlich Geistlich Hello, I own a Geistlich that is covered by recall Z-0491-2021 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.
