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.
FDA Recall Z-0268-2010 · Posted 2009-11-16
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Recalling FirmGeneric Medical Devices
Recall StatusTerminated
Product CodeFTL
Date Initiated2009-06-18
Date Terminated2012-03-14
Product Quantity15 devices
Reason for Recall
Product that is approved only for use outside the U.S. was shipped to two customers in the U.S.
Firm 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.
Root Cause
Employee error
Distribution Pattern
USA - NJ, and PA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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