Device recall
Z-1991-2016: Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for…
FDA device recall · Class II · CarboFix Orthopedics, Ltd.
Key facts
| Recall number (Z-number) | Z-1991-2016 |
|---|---|
| Recall event | 74229 |
| Product | Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. |
| Product code | HSB |
| Recalling firm | CarboFix Orthopedics, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 27, 2017 |
| 510(k) numbers | K102369, K111056, K151010, K153536 |
| FEI number | 3008820440 |
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