Device recall
Z-0171-2010: Coloplast Titan OTR Inflatable Penile Prosthesis,18cm scrotal Bioflex cylinder…
FDA device recall · Class II · Coloplast Manufacturing US, LLC
Key facts
| Recall number (Z-number) | Z-0171-2010 |
|---|---|
| Recall event | 53531 |
| Product | Coloplast Titan OTR Inflatable Penile Prosthesis,18cm scrotal Bioflex cylinder set w/OTR Pump, P/N QSR9181400. Sterile EO. Manufacturer: Coloplast A/S, 3050 Denmark. Distributed by: Coloplast Corp., Minneapolis, MN 55411 USA. Indicated for male patients suffering from erectile dysfunction who are… |
| Product code | FHW |
| Recalling firm | Coloplast Manufacturing US, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 12, 2011 |
| PMA numbers | P000006 |
| FEI number | 2125050 |
At a glance
- None 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