Device recall
Z-0344-2013: IO Fix IntraOsseous Fixation System; Extremity Medical…
FDA device recall · Class II · Extremity Medical LLC
Key facts
| Recall number (Z-number) | Z-0344-2013 |
|---|---|
| Recall event | 62916 |
| Product | IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small… |
| Product code | HWC |
| Recalling firm | Extremity Medical LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 21, 2013 |
| 510(k) numbers | K101700 |
| FEI number | 3007289093 |
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