Recall Z-0268-2010 ยท FTL Mesh, Surgical, Polymeric
Generic Medical Devices
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.
| Date | Nov 16, 2009 (initiated Jun 18, 2009) |
| Status | Terminated |
| Reason | Product that is approved only for use outside the U.S. was shipped to two customers in the U.S. |
| Root cause | Employee error |
| Action | On June 17, 2009 the recalling firm called the consignees and arranged for the unused product to be returned. On July 13, 2009 the firm sent a notification letter to the consignee that had implanted 1 of the devices. |
| Quantity | 15 devices |
| Distribution | USA - NJ, and PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083471 | GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020 Generic Medical Device, Inc., Mar 3, 2009 |