Device recall
Z-0279-2016: MiniArc Pro Single incision Sling System, Model number / Product Reference…
FDA device recall · Class II · Astora
Key facts
| Recall number (Z-number) | Z-0279-2016 |
|---|---|
| Recall event | 72552 |
| Product | MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence. |
| Product code | PAH |
| Recalling firm | Astora |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 9, 2016 |
| 510(k) numbers | K121641 |
| FEI number | 3011770902 |
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