Geistlich Pharma AG has issued a Field Safety Notice for the Geistlich Bio-Oss Pen® (ref numbers 30661.1, 30662.1, 30671.1). This is due to a small number of customer observations that a visible loose particle of green colour was seen on the outer barrel of the pen when the green filter cap was unscrewed. The particle was however discovered by the attending medical staff before use in each case. The company has not received any reports of patient injury or harm for the pen.
Geistlich Pharma AG is providing this information to all users, and would like to provide them with information on measures to be undertaken if this incident is repeated elsewhere:
“Geistlich Bio-Oss Pen Field Safety Notice“
When unscrewing the Geistlich Bio-Oss Pen® filter cap, please check for well visible and therefore easily detectable loose green/red residue or particles from the filter cap.
If a loose green/red particle from the filter cap are present, do not use the Geistlich Bio-Oss Pen® and return it to your distributor in its entirety (including any particles). Geistlich Pharma AG requires return of the Geistlich Bio-Oss Pen® concerned for examination purposes.