Device recall
Z-1481-2012: Coloplast, Restorelle DirectFix, Posterior Polypropylene Mesh, Catalogue Number…
FDA device recall · Class III · Coloplast Manufacturing US, LLC
Key facts
| Recall number (Z-number) | Z-1481-2012 |
|---|---|
| Recall event | 61411 |
| Product | Coloplast, Restorelle DirectFix, Posterior Polypropylene Mesh, Catalogue Number 501460, Rx Only, Manufacturer, Coloplast A/S 3050 Denmark Restorelle is a ploypropylene mesh that may be used for the repair of abdominal wall hernia, including inguinal, fermoral, and incisional, and uterovaginal… |
| Product code | FTL |
| Recalling firm | Coloplast Manufacturing US, LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 11, 2012 |
| 510(k) numbers | K041632, K053361 |
| FEI number | 2125050 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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