Recall Z-2147-2019 ยท NPM Bone Grafting Material, Animal Source
Geistlich Pharma North America, Inc.
Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 1-2mm 0.5g, For single use only, Part Number 20126 - 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 o
| Date | Aug 2, 2019 (initiated Apr 12, 2019) |
| Status | Terminated |
| Reason | When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen. |
| Root cause | Under Investigation by firm |
| Action | 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) |
| Quantity | 244,268 total |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120601 | GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O Geistlich Pharma AG, May 24, 2012 |