Device recall
Z-2585-2016: TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Titanium…
FDA device recall · Class II · Synthes (USA) Products LLC
Key facts
| Recall number (Z-number) | Z-2585-2016 |
|---|---|
| Recall event | 74419 |
| Product | TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or… |
| Product code | MQN |
| Recalling firm | Synthes (USA) Products LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 13, 2016 |
| 510(k) numbers | K981075 |
| FEI number | 3008812560 |
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