Z-1390-2011

The GMD UNIVERSAL URINARY INCONTINENCE SLING (Code 1010) is supplied sterile and is intended for single...

Name: Z-1390-2011 The GMD UNIVERSAL URINARY INCONTINENCE SLING (Code 1010) is supplied sterile and is intended for single...
Creator: Generic Medical Devices
Published: 2011-02-14
License: https://open.fda.gov/license/

Generic Medical Devices, Inc. / initiated 2011-02-14 / Terminated / root cause: design

FDA source

Generic Medical Devices began a recall of The GMD UNIVERSAL URINARY INCONTINENCE SLING (Code 1010) is supplied sterile and is intended for single patient use only. The GMD Universal Sling is a sterile... on 2011-02-14. The reason FDA records is "Protective sheath sticks to itself and sleeve breakage has resulted in complaints and MDRs". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1390-2011
Status: Terminated
Initiated: 2011-02-14
Posted: 2011-02-22
Terminated: 2012-09-24
Recalling firm: Generic Medical Devices, Inc.
Product: The GMD UNIVERSAL URINARY INCONTINENCE SLING (Code 1010) is supplied sterile and is intended for single patient use only. The GMD Universal Sling is a sterile, single use device for the treatment of female stress urinary incontinence. It is comprised of a polypropylene sheath with a disposable universal low density polyethylene sleeve at each end of attachment of the sling to GMD's single use or reusable trocars. The universal sleeve has three trocar insertion points, the distal and proximal trocar insertion points are for inside-out, bottom-up approaches and a sleeve end trocar insertion point is for outside-in, top-down approaches. The design allows the physician to utilize the device for placement of a polypropylene mesh at the urethra or bladder neck.
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: Protective sheath sticks to itself and sleeve breakage has resulted in complaints and MDRs.
Root cause tag: design
FDA root cause: Component design/selection
Action: The firm, GMD, issued an "URGENT MEDICAL DEVICE RECALL" letter dated February 14, 2011 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed not to use any GMD Model 1010 Universal Slings remaining in their inventory; return any Model 1010 slings in their possession to the Distributors or GMD; notify their customers to whom they shipped Model 1010s of this voluntary recall and request them to return any Model 1010 slings in their possession to them; and return all Model 1010 inventories to GMD using the attached Recalled Model 1010 Return Form. Note: Full credit in the amount of the returned products purchase price will be issued for all sterile, unexpired product returned to GMD. Contact the GMD Product Performance Senior Manager, at phone: (253) 853 3512 or email: [email protected], if you have any questions/issues related to this recall.
Quantity in commerce: approximately 1711
Distribution: Worldwide distribution: USA and countries including: Australia, Argentina, Brazil, Canada, South Africa, and Scandinavia.
Product codes and lots: All model number 1010 Universal Sleeved Slings. It cannot be determined whether each Sling is identified by an individual serial number.

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)