Device recall
Z-0356-2014: ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner…
FDA device recall · Class II · Restoration Robotics
Key facts
| Recall number (Z-number) | Z-0356-2014 |
|---|---|
| Recall event | 66558 |
| Product | ARTAS Disposable and Reuseable 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; Non-Sterile Disposable kit FP 23267 and Molded Parts, Reusable Kit FP 45538 Rx): Product Usage: Skin… |
| 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