Device recall
Z-0806-2015: AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF…
FDA device recall · Class II · American Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0806-2015 |
|---|---|
| Recall event | 69796 |
| Product | AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commercially available in the US) The AdVance Male Sling System consists of two, sterile single-use surgical instruments called helical needle passers and a mesh sling with attached connectors. One end of… |
| Product code | OTM |
| Recalling firm | American Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 28, 2015 |
| 510(k) numbers | K053371 |
| FEI number | 1000116179 |
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