Device recall
Z-0411-2011: smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface…
FDA device recall · Class II · Smith & Nephew Inc
Key facts
| Recall number (Z-number) | Z-0411-2011 |
|---|---|
| Recall event | 57047 |
| Product | smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1 Product is intended to be an intraoperative image-guided localization system. It is a computer-assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during… |
| Product code | OLO |
| Recalling firm | Smith & Nephew Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 17, 2011 |
| 510(k) numbers | K100107 |
| FEI number | 1020279 |
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