Device recall
Z-2145-2019: Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm…
FDA device recall · Class II · Geistlich Pharma North America, Inc.
Key facts
| Recall number (Z-number) | Z-2145-2019 |
|---|---|
| Recall event | 82636 |
| Product | 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… |
| Product code | NPM |
| Recalling firm | Geistlich Pharma North America, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 21, 2020 |
| 510(k) numbers | K120601 |
| FEI number | 3009439101 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database