Device recall
Z-0354-2014: ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with…
FDA device recall · Class II · Restoration Robotics
Key facts
| Recall number (Z-number) | Z-0354-2014 |
|---|---|
| Recall event | 66558 |
| Product | ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; Dissection Punch 4.0mm FP-23304; Saline Nose Cone FP-45387; Follicle Trap - FP-23306 and Non-sterile Disposable Clinical Kit FP -23267): and ARTAS Disposable Kits, 18 Gauge Epsilon (Contains Disposable… |
| Product code | ONA |
| Recalling firm | Restoration Robotics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 10, 2013 |
| 510(k) numbers | K123548 |
| FEI number | 3006515340 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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