Device recall
Z-0136-2017: Agee-WristJack Fracture Reduction System; Item number: CFD-147. The WristJack…
FDA device recall · Class II · Hand Biomechanics Lab Inc
Key facts
| Recall number (Z-number) | Z-0136-2017 |
|---|---|
| Recall event | 75255 |
| Product | Agee-WristJack Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack Fracture Reduction System… |
| Product code | JEC |
| Recalling firm | Hand Biomechanics Lab Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 15, 2016 |
| 510(k) numbers | K984442 |
| FEI number | 2919128 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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