Device recall
Z-1922-2016: Actifuse ABX/Actifuse MIS System A bone void filler intended only for orthopedic…
FDA device recall · Class II · Apatech Limited
Key facts
| Recall number (Z-number) | Z-1922-2016 |
|---|---|
| Recall event | 74125 |
| Product | Actifuse ABX/Actifuse MIS System A bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. |
| Product code | MQV |
| Recalling firm | Apatech Limited |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 31, 2018 |
| 510(k) numbers | K071206, K081979, K082575, K090850 |
| FEI number | 3004450973 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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