Device recall
Z-1916-2018: Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in…
FDA device recall · Class II · Synthes (USA) Products LLC
Key facts
| Recall number (Z-number) | Z-1916-2018 |
|---|---|
| Recall event | 80048 |
| Product | Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation. |
| Product code | HXX |
| Recalling firm | Synthes (USA) Products LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 21, 2019 |
| FEI number | 3008812560 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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