Device recall
Z-1016-2013: Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known…
FDA device recall · Class II · Synthes USA HQ, Inc.
Key facts
| Recall number (Z-number) | Z-1016-2013 |
|---|---|
| Recall event | 64271 |
| Product | Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Dens instrument Set has been designed to facilitate internal fixation of the odontoid process for the reduction of Type II and shallow Type III fractures, as proposed by… |
| Product code | HWC |
| Recalling firm | Synthes USA HQ, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 10, 2015 |
| FEI number | 3005180112 |
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