Device recall
Z-1390-2011: The GMD UNIVERSAL URINARY INCONTINENCE SLING (Code 1010) is supplied sterile and…
FDA device recall · Class II · Generic Medical Devices
Key facts
| Recall number (Z-number) | Z-1390-2011 |
|---|---|
| Recall event | 56670 |
| Product | The GMD UNIVERSAL URINARY INCONTINENCE SLING (Code 1010) is supplied sterile and is intended for single patient use only. The GMD Universal Sling is a sterile, single use device for the treatment of female stress urinary incontinence. It is comprised of a polypropylene sheath with a disposable… |
| Product code | FTL |
| Recalling firm | Generic Medical Devices |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 24, 2012 |
| 510(k) numbers | K083471 |
| FEI number | 3006142121 |
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