FDA Recall
Terminated
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.
Recall: Z-0268-2010
·
Initiated June 18, 2009
Recall
- Recall Number
- Z-0268-2010
- Event Number
- 52546
- Firm
- Generic Medical Devices
- FEI Number
- 3006142121
- Product Code
- FTL
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- June 18, 2009
- Posted
- November 16, 2009
- Terminated
- March 14, 2012
- Address
- 5727 Baker Way NW, Suite 201, Gig Harbor, WA, 98332
Description
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.
Reason
Product that is approved only for use outside the U.S. was shipped to two customers in the U.S.
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.
Distribution
USA - NJ, and PA
Quantity
15 devices