Device recall
Z-1174-2014: Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes…
FDA device recall · Class II · Synthes, Inc.
Key facts
| Recall number (Z-number) | Z-1174-2014 |
|---|---|
| Recall event | 67391 |
| Product | Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants accommodates variable… |
| Product code | HRS |
| Recalling firm | Synthes, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 26, 2016 |
| 510(k) numbers | K915818 |
| FEI number | 3005180112 |
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