Z-0268-2010

GMD UNIVERSAL URINARY INCONTINENCE SLING, Rx ONLY Product Code 1020-18. Intended for use in women as a...

Name: Z-0268-2010 GMD UNIVERSAL URINARY INCONTINENCE SLING, Rx ONLY Product Code 1020-18. Intended for use in women as a...
Creator: Generic Medical Devices
Published: 2009-06-18
License: https://open.fda.gov/license/

Generic Medical Devices, Inc. / initiated 2009-06-18 / Terminated / root cause: manufacturing process

FDA source

Generic Medical Devices began a recall of 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... on 2009-06-18. The reason FDA records is "Product that is approved only for use outside the U.S. was shipped to two customers in the U.S". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0268-2010
Status: Terminated
Initiated: 2009-06-18
Posted: 2009-11-16
Terminated: 2012-03-14
Recalling firm: Generic Medical Devices, Inc.
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 Mesh, Surgical, Polymeric
Reason for recall: Product that is approved only for use outside the U.S. was shipped to two customers in the U.S.
Root cause tag: manufacturing process
FDA 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 in commerce: 15 devices
Distribution: USA - NJ, and PA
Product codes and lots: Lot number 21664

Product code FTL

K083471Class IIGmd Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. / cleared 2009-03-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)