Device recall
Z-0446-2012: Osteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C, Osteoplug, and…
FDA device recall · Class II · OSTEOPORE INTERNATIONAL PTE LTD
Key facts
| Recall number (Z-number) | Z-0446-2012 |
|---|---|
| Recall event | 59231 |
| Product | Osteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C, Osteoplug, and Osteomesh. |
| Product code | GXP |
| Recalling firm | OSTEOPORE INTERNATIONAL PTE LTD |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 6, 2012 |
| 510(k) numbers | K051093 |
| FEI number | 3007303685 |
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