Device recall
Z-2187-2020: OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usage…
FDA device recall · Class II · Osteomed, LLC
Key facts
| Recall number (Z-number) | Z-2187-2020 |
|---|---|
| Recall event | 85529 |
| Product | OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process. |
| Product code | MQV |
| Recalling firm | Osteomed, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 5, 2021 |
| 510(k) numbers | K051784 |
| FEI number | 2027754 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 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