Device recall
Z-0934-2014: 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No…
FDA device recall · Class II · OrthoPediatrics Corp
Key facts
| Recall number (Z-number) | Z-0934-2014 |
|---|---|
| Recall event | 67302 |
| Product | 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone Screw designed for use with… |
| Product code | HWC |
| Recalling firm | OrthoPediatrics Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 23, 2014 |
| FEI number | 3006460162 |
At a glance
- None 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