Device recall
Z-0615-2014: Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes…
FDA device recall · Class II · Synthes USA HQ, Inc.
Key facts
| Recall number (Z-number) | Z-0615-2014 |
|---|---|
| Recall event | 65007 |
| Product | Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 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… |
| Product code | HWE |
| Recalling firm | Synthes USA HQ, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 14, 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