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U.S. Department of Health and Human Services

Class 2 Device Recall GMD UNIVERSAL URINARY INCONTINENCE SLING

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  Class 2 Device Recall GMD UNIVERSAL URINARY INCONTINENCE SLING see related information
Date Initiated by Firm February 14, 2011
Date Posted February 22, 2011
Recall Status1 Terminated 3 on September 24, 2012
Recall Number Z-1390-2011
Recall Event ID 56670
510(K)Number K083471  
Product Classification Mesh, surgical, polymeric - Product Code FTL
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.
Code Information All model number 1010 Universal Sleeved Slings. It cannot be determined whether each Sling is identified by an individual serial number.
Recalling Firm/
Manufacturer		 Generic Medical Devices
5727 Baker Way Nw Ste 201
Gig Harbor WA 98332-5811
For Additional Information Contact
253-853-3594
Manufacturer Reason
for Recall		 Protective sheath sticks to itself and sleeve breakage has resulted in complaints and MDRs.
FDA Determined
Cause 2		 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: 1010recall@gmd-us.com, 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.
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 and Original Applicant = GENERIC MEDICAL DEVICE, INC.
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