FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0268-2010
- Recalling firm
- Generic Medical Devices
- 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.
- Status
- Terminated
- Initiated
- 2009-06-18
- Posted
- 2009-11-16
- Terminated
- 2012-03-14
- 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
- Lot, serial or model codes
- Lot number 21664
- 510(k) numbers
- ["K083471"]
- PMA numbers
- not on file
- Product code
- FTL
- Firm FEI
- 3006142121
- Firm city
- Gig Harbor
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28