Device recall
Z-1313-2015: Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is…
FDA device recall · Class II · Synthes, Inc.
Key facts
| Recall number (Z-number) | Z-1313-2015 |
|---|---|
| Recall event | 70247 |
| Product | Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to… |
| Product code | HWE |
| Recalling firm | Synthes, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 19, 2016 |
| 510(k) numbers | K043310 |
| 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