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Geistlich Pharma North America Recalls
6 recalls on record · August 14, 2019 to December 2, 2020 · Medical Devices
Recalls by year
19
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 2, 2020Medical DevicesFDA
Geistlich Pharma North America, Inc. recalls Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surg
Hazard: 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
December 2, 2020Medical DevicesFDA
Geistlich Pharma North America, Inc. recalls Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial s
Hazard: 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
December 2, 2020Medical DevicesFDA
Geistlich Pharma North America, Inc. recalls Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial
Hazard: 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
August 14, 2019Medical DevicesFDA
Geistlich Pharma North America, Inc. recalls Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 1-2mm 0.5g, For single use only, Part Number 20126
Hazard: When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
August 14, 2019Medical DevicesFDA
Geistlich Pharma North America, Inc. recalls Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.5g, For single use only, Part Number 20
Hazard: When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
August 14, 2019Medical DevicesFDA
Geistlich Pharma North America, Inc. recalls Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number 2
Hazard: When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.