Class 3 Device Recall suburethral sling

• Date Initiated by Firm: June 18, 2009
• Date Posted: November 16, 2009
• Recall Status: Terminated on March 14, 2012
• Recall Number: Z-0268-2010
• Recall Event ID: 52546
• 510(K)Number: K083471
• Product Classification: Surgical mesh - Product Code FTL
• 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.
• Code Information: Lot number 21664
• FEI Number: 3006142121
• Recalling Firm/ Manufacturer: Generic Medical Devices; 5727 Baker Way NW; Suite 201; Gig Harbor WA 98332
• For Additional Information Contact: Monica R. Montanez; 253-853-3594
• Manufacturer Reason for Recall: Product that is approved only for use outside the U.S. was shipped to two customers in the U.S.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FTL