GMD Universal Urinary Incontinence Sling…

Date posted by the FDA

Nov. 16, 2009

Status

Terminated

Filed by

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.

Reason

Product that is approved only for use outside the U.S. was shipped to two customers in the U.S.

Distribution pattern

USA - NJ, and PA

Quantity

15 devices

Codes and lots

Lot number 21664

Recall started

June 18, 2009

Device type

Mesh, Surgical, Polymeric

Root cause (FDA)

Employee error

What the company told customers

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.

Recall number

Z-0268-2010

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0268-2010. The agency record governs; check it and the company before acting.