Device recall
Z-0268-2010: GMD UNIVERSAL URINARY INCONTINENCE SLING, Rx ONLY Product Code 1020-18. Intended…
FDA device recall · Class III · Generic Medical Devices
Key facts
| Recall number (Z-number) | Z-0268-2010 |
|---|---|
| Recall event | 52546 |
| Product | GMD UNIVERSAL URINARY INCONTINENCE SLING, Rx ONLY Product Code 1020-18. Intended for use in women as a suburethral sling for the treatment of stress urinary incontinence resulting from either urethral hypermobility and/or intrinsic sphincter deficiency. |
| Product code | FTL |
| Recalling firm | Generic Medical Devices |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 14, 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