Device recall
Z-2057-2013: Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting…
FDA device recall · Class II · Synthes (USA) Products LLC
Key facts
| Recall number (Z-number) | Z-2057-2013 |
|---|---|
| Recall event | 65556 |
| Product | Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. |
| Product code | HRS |
| Recalling firm | Synthes (USA) Products LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 21, 2015 |
| 510(k) numbers | K071184, K083694, K092556 |
| FEI number | 3008812560 |
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