Device recall
Z-0866-2021: OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing…
FDA device recall · Class II · Skeletal Kinetics, Llc
Key facts
| Recall number (Z-number) | Z-0866-2021 |
|---|---|
| Recall event | 85133 |
| Product | OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process. |
| Product code | GXP |
| Recalling firm | Skeletal Kinetics, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 18, 2024 |
| 510(k) numbers | K051784 |
| FEI number | 3003890476 |
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