Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number 20115 - Product Usage: Augmentation or reconstructive treatment of the alveolar ridge; Filling of infrabony periodontal defects; Filling of defects after root resection, apicoectomy and cystectomy; Filling of extraction sockets to enhance preservation of the alveolar ridge; Elevation of the maxillary sinus floor, etc.

When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.

On April 12, 2019, Geistlich Pharma AG issued URGENT MEDICAL DEVICE CORRECTION NOTICES and Acknowledgement and Receipt Forms to customers via courier service. Customers were advised to take the following actions: 1) When using the device, please assure that the green cap is removed without force, and when removing the filter cap, the cap is turned to the left to loosen as overtightening could damage the cap. 2) Should you observe a similar plastic fragment, DO NOT use the product. Please retain the product and notify the firm by calling 855-799-5500 to arrange a return and replacement. 3) Customers requesting return of product call 855-799-5500 4) Complete and return the Acknowledgement form via email to [email protected] 5) Notify all clinicians within your practice by sharing a copy of the notice.