Device recall
Z-0353-2014: Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if…
FDA device recall · Class II · Restoration Robotics
Key facts
| Recall number (Z-number) | Z-0353-2014 |
|---|---|
| Recall event | 66558 |
| Product | Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions. |
| 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