Device recall
Z-0349-2010: Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Rt, non-sterile, Orthopediatrics…
FDA device recall · Class II · Orthopediatrics Corp
Key facts
| Recall number (Z-number) | Z-0349-2010 |
|---|---|
| Recall event | 52852 |
| Product | Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-035. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic… |
| Product code | HSB |
| Recalling firm | Orthopediatrics Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 25, 2010 |
| 510(k) numbers | K083726 |
| FEI number | 3006460162 |
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